Contract manufacturerParagon Medical Inc. (Smithfield, UT)UtahGeneral and plastic surgeryNeurologyOrthopedicClass IClass II
Paragon Medical Inc.
Contract manufacturer · Smithfield, UT
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1000517406 (openFDA record; or search FDA's registration database)
- FEI number
- 1000517406
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Paragon Medical (FDA owner/operator no. 9011072)
- Registered address
- 125 W 1000 S, Smithfield, UT 84335
- Contract listings
- 84 device listings, 67 product codes, first listed Dec 28, 2007
- 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 |
|---|---|---|---|---|---|
| FZX | Guide, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Jan 17, 2013 |
| FZY | Hammer, Surgical | Class I | General and plastic surgery | Contract manufacturing | Jun 16, 2020 |
| GAD | Retractor | Class I | General and plastic surgery | Contract manufacturing | Jan 30, 2013 |
| GCC | Dilator, Catheter | Class I | General and plastic surgery | Contract manufacturing | Jan 31, 2013 |
| GEA | Cannula, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Jan 30, 2013 |
| GEF | Applier, Staple, Surgical, | Class I | General and plastic surgery | Contract manufacturing | Nov 1, 2015 |
| GEG | Elevator, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Jan 30, 2013 |
| GFG | Bit, Surgical | Class I | General and plastic surgery | Contract manufacturing | Jan 30, 2013 |
| HAO | Instrument, Surgical, Non-Powered | Class I | Neurology | Contract manufacturing | Feb 16, 2017 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Oct 18, 2012 |
| HRX | Arthroscope | Class II | Orthopedic | Contract manufacturing | Nov 5, 2024 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jan 18, 2013 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | Contract manufacturing | Jun 16, 2020 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Class II | Orthopedic | Contract manufacturing | May 11, 2022 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jan 18, 2013 |
| HTJ | Gauge, Depth | Class I | Orthopedic | Contract manufacturing | Jan 17, 2013 |
| HTN | Washer, Bolt Nut | Class II | Orthopedic | Contract manufacturing | Aug 25, 2016 |
| HTO | Reamer | Class I | Orthopedic | Contract manufacturing | Jan 17, 2013 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| HTY | Pin, Fixation, Smooth | Class II | Orthopedic | Contract manufacturing | Jan 18, 2013 |
| HWA | Impactor | Class I | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| HWB | Extractor | Class I | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Oct 18, 2012 |
| HWD | Starter, Bone Screw | Class I | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract manufacturing | Jan 27, 2015 |
| HWJ | Awl | Class I | Orthopedic | Contract manufacturing | Oct 14, 2008 |
| HWR | Driver, Prosthesis | Class I | Orthopedic | Contract manufacturing | Jan 20, 2013 |
| HWT | Template | Class I | Orthopedic | Contract manufacturing | Jan 20, 2013 |
| HWX | Tap, Bone | Class I | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| HXL | Mallet | Class I | General and plastic surgery | Contract manufacturing | Jun 5, 2017 |
| HXP | Instrument, Bending Or Contouring | Class I | Orthopedic | Contract manufacturing | Jul 7, 2021 |
| HXX | Screwdriver | Class I | Orthopedic | Contract manufacturing | Jan 20, 2013 |
| JDW | Pin, Fixation, Threaded | Class II | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jan 18, 2013 |
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract manufacturing | May 11, 2022 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jan 18, 2013 |
| KRQ | Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jan 18, 2013 |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jan 18, 2013 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class II | Orthopedic | Contract manufacturing | Jan 18, 2013 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Jan 17, 2013 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract manufacturing | Jan 17, 2013 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | May 11, 2022 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | May 11, 2022 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | Contract manufacturing | Feb 15, 2017 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Dec 28, 2007 |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | Class II | Orthopedic | Contract manufacturing | Jan 18, 2013 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Class II | Orthopedic | Contract manufacturing | Oct 26, 2015 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract manufacturing | Nov 24, 2025 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Class II | Orthopedic | Contract manufacturing | May 11, 2022 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jan 18, 2013 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract manufacturing | Oct 14, 2008 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract manufacturing | Jan 17, 2013 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract manufacturing | Jan 17, 2013 |
| MQP | Spinal Vertebral Body Replacement Device | Class II | Orthopedic | Contract manufacturing | Jan 17, 2013 |
| NBH | Accessories, Arthroscopic | Class I | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract manufacturing | Jan 18, 2013 |
| NKG | Posterior Cervical Screw System | Class II | Orthopedic | Contract manufacturing | Nov 24, 2025 |
| NPJ | Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jan 18, 2013 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | Contract manufacturing | Nov 24, 2025 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Jun 5, 2024 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Class II | Orthopedic | Contract manufacturing | Jan 18, 2013 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | Contract manufacturing | Jan 17, 2013 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | Contract manufacturing | Jan 18, 2013 |
| OWI | Bone Fixation Cerclage, Sublaminar | Class II | Orthopedic | Contract manufacturing | Nov 24, 2025 |
| PAO | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | Class II | Orthopedic | Contract manufacturing | May 11, 2022 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Class II | Orthopedic | Contract manufacturing | May 11, 2022 |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | Class II | Orthopedic | Contract manufacturing | May 9, 2025 |