Contract manufacturerPRECISION EDGE SURGICAL PRODUCTS COMPANY (Sault Sainte Marie, MI)MichiganGeneral and plastic surgeryDentalEar, nose and throatNeurologyOrthopedicClass IClass II
PRECISION EDGE SURGICAL PRODUCTS COMPANY
Contract manufacturer · Sault Sainte Marie, MI
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1833986 (openFDA record; or search FDA's registration database)
- FEI number
- 1000139987
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer for export only; Contract manufacturer
- Owner or operator
- Precision Edge Surgical Products Company (FDA owner/operator no. 10042577)
- Registered address
- 415 W 12th Ave, Sault Sainte Marie, MI 49783
- Contract listings
- 85 device listings, 70 product codes, first listed Dec 10, 2012
- 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 |
|---|---|---|---|---|---|
| DWH | Blade, Saw, Surgical, Cardiovascular | Class I | General and plastic surgery | Contract manufacturing | Apr 6, 2021 |
| DZJ | Driver, Wire, And Bone Drill, Manual | Class II | Dental | Contract manufacturing | Jan 11, 2024 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Class II | Ear, nose and throat | Contract manufacturing | Dec 26, 2012 |
| FSM | Tray, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Jul 27, 2021 |
| FZS | Curette, Surgical, General Use | Class I | General and plastic surgery | Contract manufacturing | Jul 28, 2023 |
| FZX | Guide, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Nov 8, 2018 |
| GAC | Rasp, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Dec 11, 2012 |
| GEA | Cannula, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Sep 13, 2018 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | Class I | General and plastic surgery | Contract manufacturing | Dec 11, 2012 |
| GFE | Brush, Dermabrasion, Powered | Class I | General and plastic surgery | Contract manufacturing | Mar 9, 2021 |
| GFF | Bur, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Dec 17, 2012 |
| GFG | Bit, Surgical | Class I | General and plastic surgery | Contract manufacturing | Nov 19, 2018 |
| GFI | Osteotome, Manual | Class I | General and plastic surgery | Contract manufacturing | Jan 11, 2024 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | Class II | Neurology | Contract manufacturing | Dec 26, 2012 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Aug 23, 2018 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | Contract manufacturing | Jun 20, 2016 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Class II | Orthopedic | Contract manufacturing | Dec 10, 2012 |
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | Class I | General and plastic surgery | Contract manufacturing | Dec 14, 2018 |
| HTD | Forceps | Class I | General and plastic surgery | Contract manufacturing | Jan 10, 2024 |
| HTJ | Gauge, Depth | Class I | Orthopedic | Contract manufacturing | Jun 20, 2016 |
| HTN | Washer, Bolt Nut | Class II | Orthopedic | Contract manufacturing | Aug 2, 2017 |
| HTO | Reamer | Class I | Orthopedic | Contract manufacturing | Dec 10, 2012 |
| HTT | Burr, Orthopedic | Class I | Orthopedic | Contract manufacturing | Dec 11, 2012 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract manufacturing | Dec 10, 2012 |
| HTY | Pin, Fixation, Smooth | Class II | Orthopedic | Contract manufacturing | Aug 19, 2025 |
| HWB | Extractor | Class I | Orthopedic | Contract manufacturing | Jun 20, 2016 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Jul 21, 2016 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract manufacturing | Dec 26, 2012 |
| HWJ | Awl | Class I | Orthopedic | Contract manufacturing | Nov 8, 2018 |
| HWK | Trephine | Class I | Orthopedic | Contract manufacturing | Nov 8, 2018 |
| HWN | Instrument, Compression | Class I | Orthopedic | Contract manufacturing | Jun 20, 2016 |
| HWT | Template | Class I | Orthopedic | Contract manufacturing | Oct 18, 2024 |
| HWW | Countersink | Class I | Orthopedic | Contract manufacturing | May 20, 2020 |
| HWX | Tap, Bone | Class I | Orthopedic | Contract manufacturing | Apr 17, 2017 |
| HXC | Wrench | Class I | Orthopedic | Contract manufacturing | Jun 11, 2024 |
| HXG | Tamp | Class I | Orthopedic | Contract manufacturing | Jan 30, 2025 |
| HXI | Passer, Wire, Orthopedic | Class I | Orthopedic | Contract manufacturing | Jan 4, 2021 |
| HXX | Screwdriver | Class I | Orthopedic | Contract manufacturing | Nov 8, 2018 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Class II | Orthopedic | Contract manufacturing | Dec 10, 2012 |
| JDQ | Cerclage, Fixation | Class II | Orthopedic | Contract manufacturing | Jan 21, 2013 |
| JDR | Staple, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Aug 2, 2017 |
| JDW | Pin, Fixation, Threaded | Class II | Orthopedic | Contract manufacturing | Aug 19, 2025 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jul 12, 2023 |
| KIK | Hook, Bone | Class I | General and plastic surgery | Contract manufacturing | Nov 8, 2018 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Dec 10, 2012 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class II | Orthopedic | Contract manufacturing | Jun 20, 2016 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | Class II | Orthopedic | Contract manufacturing | Dec 10, 2012 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Jan 21, 2013 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract manufacturing | Jan 21, 2013 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | Dec 10, 2012 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | Dec 10, 2012 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class II | Orthopedic | Contract manufacturing | Dec 10, 2012 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Dec 10, 2012 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | Contract manufacturing | Dec 10, 2012 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Class II | Orthopedic | Contract manufacturing | Dec 10, 2012 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Jan 14, 2013 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | Contract manufacturing | Dec 10, 2012 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract manufacturing | Jan 21, 2013 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jul 12, 2023 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract manufacturing | Jan 14, 2013 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract manufacturing | Jan 21, 2013 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract manufacturing | Jan 21, 2013 |
| MQP | Spinal Vertebral Body Replacement Device | Class II | Orthopedic | Contract manufacturing | Jan 21, 2013 |
| NBH | Accessories, Arthroscopic | Class I | Orthopedic | Contract manufacturing | Jan 14, 2013 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | Contract manufacturing | Jan 21, 2013 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Oct 30, 2020 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Class II | Orthopedic | Contract manufacturing | Jan 21, 2013 |
| OSN | Software For Diagnosis/Treatment | Class II | Orthopedic | Contract manufacturing | Aug 19, 2025 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | Contract manufacturing | Jan 21, 2013 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | Contract manufacturing | Jan 21, 2013 |