Contract manufacturerMACH MEDICAL (Columbia City, IN)IndianaOrthopedicGeneral and plastic surgeryNeurologyClass IIClass I
MACH MEDICAL
Contract manufacturer · Columbia City, IN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3020703621 (openFDA record; or search FDA's registration database)
- FEI number
- 3020703621
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Mach Medical, LLC (FDA owner/operator no. 10082639)
- Registered address
- 4707 East Park 30 Drive, Columbia City, IN 46725
- Contract listings
- 17 device listings, 12 product codes, first listed Sep 8, 2021
- 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 |
|---|---|---|---|---|---|
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Dec 15, 2023 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Dec 5, 2025 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Dec 5, 2025 |
| HTR | Rasp | Class I | General and plastic surgery | Contract manufacturing | Jan 9, 2025 |
| JDR | Staple, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Dec 12, 2024 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Sep 8, 2021 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Dec 12, 2024 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | Class II | Orthopedic | Contract manufacturing | Dec 12, 2024 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract manufacturing | Dec 15, 2023 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Dec 15, 2023 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Class II | Orthopedic | Contract manufacturing | Dec 5, 2025 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Dec 15, 2023 |