Contract manufacturerTRACER ORTHOPEDICS (Oakland, NJ)New JerseyGeneral and plastic surgeryOrthopedicEar, nose and throatClass IClass II
TRACER ORTHOPEDICS
Contract manufacturer · Oakland, NJ
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2249608 (openFDA record; or search FDA's registration database)
- FEI number
- 3002943267
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- TRACER ORTHOPEDICS (FDA owner/operator no. 10042852)
- Registered address
- 32 IRON HORSE ROAD, Oakland, NJ 07436
- Contract listings
- 8 device listings, 8 product codes, first listed Jan 7, 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 |
|---|---|---|---|---|---|
| FSM | Tray, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Oct 5, 2020 |
| FZX | Guide, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Sep 3, 2020 |
| HTR | Rasp | Class I | General and plastic surgery | Contract manufacturing | Sep 3, 2020 |
| HXX | Screwdriver | Class I | Orthopedic | Contract manufacturing | Sep 3, 2020 |
| KAR | Irrigator, Sinus | Class I | Ear, nose and throat | Contract manufacturing | Sep 3, 2020 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Jan 7, 2013 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract manufacturing | Oct 23, 2020 |
| QHE | Shoulder Arthroplasty Implantation System | Class II | Orthopedic | Contract manufacturing | May 20, 2025 |