Contract manufacturerSUMMIT MFG. AND MACHINING, INC. (Bremen, IN)IndianaGeneral and plastic surgeryOrthopedicClass I
SUMMIT MFG. AND MACHINING, INC.
Contract manufacturer ยท Bremen, IN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3004504812 (openFDA record; or search FDA's registration database)
- FEI number
- 3004504812
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Summit Mfg. And Machining, Inc. (FDA owner/operator no. 10043195)
- Registered address
- 723 High Rd, Bremen, IN 46506
- Contract listings
- 7 device listings, 7 product codes, first listed Jan 30, 2013
- 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 30, 2013 |
| HWP | Punch, Femoral Neck | Class I | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| HWT | Template | Class I | Orthopedic | Contract manufacturing | Jan 26, 2022 |
| HXX | Screwdriver | Class I | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| HXZ | Cutter, Wire | Class I | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| NBH | Accessories, Arthroscopic | Class I | Orthopedic | Contract manufacturing | Mar 29, 2023 |