Contract manufacturerMetal Craft Machine & Engineering, Inc. (Elk River, MN)MinnesotaCardiovascularGeneral and plastic surgeryNeurologyOrthopedicEar, nose and throatGastroenterology and urologyClass IIClass IClass IIIUnclassified
Metal Craft Machine & Engineering, Inc.
Contract manufacturer ยท Elk River, MN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2133928 (openFDA record; or search FDA's registration database)
- FEI number
- 3000717902
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Metal Craft and Riverside Machine & Engineering, Inc. (FDA owner/operator no. 9027247)
- Registered address
- 13760 Business Center Drive, Elk River, MN 55330
- Contract listings
- 102 device listings, 89 product codes, first listed Jan 14, 2009
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| DQX | Wire, Guide, Catheter | Class II | Cardiovascular | Contract manufacturing | Feb 1, 2013 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | Class II | Cardiovascular | Contract manufacturing | Feb 1, 2013 |
| DTJ | Holder, Heart-Valve, Prosthesis | Class I | Cardiovascular | Contract manufacturing | Jan 31, 2013 |
| DWS | Instruments, Surgical, Cardiovascular | Class I | Cardiovascular | Contract manufacturing | Feb 1, 2013 |
| DXO | Transducer, Pressure, Catheter Tip | Class II | Cardiovascular | Contract manufacturing | Feb 1, 2013 |
| FSM | Tray, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Apr 6, 2013 |
| FSZ | Light, Surgical, Carrier | Class II | General and plastic surgery | Contract manufacturing | Dec 3, 2012 |
| FTY | Tape, Measuring, Rulers And Calipers | Class I | General and plastic surgery | Contract manufacturing | Apr 6, 2013 |
| FZO | Chisel, Surgical, Manual | Class I | General and plastic surgery | Contract manufacturing | Apr 6, 2013 |
| FZX | Guide, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Jan 31, 2013 |
| FZY | Hammer, Surgical | Class I | General and plastic surgery | Contract manufacturing | Apr 22, 2013 |
| GAC | Rasp, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Jan 31, 2013 |
| GAD | Retractor | Class I | General and plastic surgery | Contract manufacturing | Dec 3, 2012 |
| GCC | Dilator, Catheter | Class I | General and plastic surgery | Contract manufacturing | Jan 31, 2013 |
| GCZ | Retainer, Surgical | Class I | General and plastic surgery | Contract manufacturing | Apr 22, 2013 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Dec 19, 2013 |
| GEA | Cannula, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Apr 22, 2013 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract manufacturing | Feb 1, 2013 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | Class I | General and plastic surgery | Contract manufacturing | Apr 22, 2013 |
| GFC | Driver, Surgical, Pin | Class I | General and plastic surgery | Contract manufacturing | Apr 22, 2013 |
| GFF | Bur, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Jan 31, 2013 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | Class II | Neurology | Contract manufacturing | Jan 31, 2013 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Feb 1, 2013 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Feb 1, 2013 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | Contract manufacturing | Feb 1, 2013 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Class II | Orthopedic | Contract manufacturing | Mar 25, 2019 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Feb 6, 2013 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Feb 1, 2013 |
| HTD | Forceps | Class I | General and plastic surgery | Contract manufacturing | Apr 22, 2013 |
| HTJ | Gauge, Depth | Class I | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| HTO | Reamer | Class I | Orthopedic | Contract manufacturing | Jan 22, 2013 |
| HTR | Rasp | Class I | General and plastic surgery | Contract manufacturing | Jan 31, 2013 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract manufacturing | Feb 1, 2013 |
| HWA | Impactor | Class I | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Feb 6, 2013 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract manufacturing | Feb 6, 2013 |
| HWJ | Awl | Class I | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| HWK | Trephine | Class I | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| HWP | Punch, Femoral Neck | Class I | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| HWR | Driver, Prosthesis | Class I | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| HWT | Template | Class I | Orthopedic | Contract manufacturing | Dec 8, 2012 |
| HWX | Tap, Bone | Class I | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| HXB | Probe | Class I | Orthopedic | Contract manufacturing | May 17, 2013 |
| HXC | Wrench | Class I | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| HXD | Clamp | Class I | General and plastic surgery | Contract manufacturing | Jan 31, 2013 |
| HXG | Tamp | Class I | Orthopedic | Contract manufacturing | May 17, 2013 |
| HXW | Bender | Class I | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| HXX | Screwdriver | Class I | Orthopedic | Contract manufacturing | Dec 5, 2012 |
| JDB | Prosthesis, Elbow, Semi-Constrained, Cemented | Class II | Orthopedic | Contract manufacturing | Mar 28, 2016 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Class II | Orthopedic | Contract manufacturing | Jan 12, 2015 |
| JDQ | Cerclage, Fixation | Class II | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Feb 1, 2013 |
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | Class II | Orthopedic | Contract manufacturing | Mar 28, 2016 |
| KCH | Hook, Tracheal | Class I | Ear, nose and throat | Contract manufacturing | Jun 7, 2013 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Feb 22, 2023 |
| KTZ | Caliper | Class I | Orthopedic | Contract manufacturing | Dec 20, 2013 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | Class II | Orthopedic | Contract manufacturing | Mar 28, 2016 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | Class II | Orthopedic | Contract manufacturing | Jan 12, 2015 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract manufacturing | Dec 8, 2012 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | Mar 25, 2019 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | Mar 25, 2019 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class II | Orthopedic | Contract manufacturing | Jan 12, 2015 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jan 12, 2015 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | Contract manufacturing | Jan 12, 2015 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Class II | Orthopedic | Contract manufacturing | Jan 12, 2015 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Jan 14, 2009 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | Contract manufacturing | Jan 12, 2015 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract manufacturing | Dec 8, 2012 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jan 12, 2015 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract manufacturing | Feb 1, 2013 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Class II | Orthopedic | Contract manufacturing | Jan 12, 2015 |
| MJO | Prosthesis, Intervertebral Disc | Class III | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| MQP | Spinal Vertebral Body Replacement Device | Class II | Orthopedic | Contract manufacturing | Dec 8, 2012 |
| MRW | System, Facet Screw Spinal Device | Unclassified | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| NBH | Accessories, Arthroscopic | Class I | Orthopedic | Contract manufacturing | Dec 3, 2012 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract manufacturing | Apr 6, 2013 |
| NQP | Posterior Metal/Polymer Spinal System, Fusion | Class II | Orthopedic | Contract manufacturing | Dec 31, 2014 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Dec 15, 2017 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Class II | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| OUR | Sacroiliac Joint Fixation | Class II | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Class II | Orthopedic | Contract manufacturing | Mar 25, 2019 |
| QGA | Penile Implant Surgical Accessories | Class I | Gastroenterology and urology | Contract manufacturing | Apr 9, 2020 |
| QGD | Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories | Class I | Gastroenterology and urology | Contract manufacturing | Apr 9, 2020 |