Contract manufacturerParagon Medical Inc. (Castleton, IN)IndianaGeneral and plastic surgeryOrthopedicClass IIClass I
Paragon Medical Inc.
Contract manufacturer ยท Castleton, IN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1835831 (openFDA record; or search FDA's registration database)
- FEI number
- 3001814066
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Paragon Medical (FDA owner/operator no. 9011072)
- Registered address
- 7350 E. 86TH ST., Castleton, IN 46256
- Contract listings
- 37 device listings, 35 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 |
|---|---|---|---|---|---|
| EZX | Mesh, Surgical, Metal | Class II | General and plastic surgery | Contract manufacturing | Jan 30, 2013 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Oct 18, 2012 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Class II | Orthopedic | Contract manufacturing | Dec 15, 2017 |
| HTN | Washer, Bolt Nut | Class II | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| HTY | Pin, Fixation, Smooth | Class II | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| HTZ | Instrument, Cutting, Orthopedic | Class I | General and plastic surgery | Contract manufacturing | May 31, 2017 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Oct 18, 2012 |
| HWR | Driver, Prosthesis | Class I | Orthopedic | Contract manufacturing | Jan 20, 2013 |
| HWT | Template | Class I | Orthopedic | Contract manufacturing | Jan 20, 2013 |
| JDR | Staple, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Feb 7, 2018 |
| JDW | Pin, Fixation, Threaded | Class II | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract manufacturing | May 11, 2022 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class II | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | Dec 15, 2017 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | May 11, 2022 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class II | Orthopedic | Contract manufacturing | Aug 12, 2024 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Aug 12, 2024 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Class II | Orthopedic | Contract manufacturing | Aug 12, 2024 |
| 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 31, 2013 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | Contract manufacturing | Aug 12, 2024 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Class II | Orthopedic | Contract manufacturing | May 11, 2022 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract manufacturing | Oct 14, 2008 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Class II | Orthopedic | Contract manufacturing | Aug 12, 2024 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| MQP | Spinal Vertebral Body Replacement Device | Class II | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| NKG | Posterior Cervical Screw System | Class II | Orthopedic | Contract manufacturing | Jan 7, 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 | Dec 15, 2017 |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | Class II | Orthopedic | Contract manufacturing | May 12, 2022 |