Contract manufacturerTECOMET (Woburn, MA)MassachusettsDentalGeneral and plastic surgeryNeurologyOrthopedicClass IIClass I
TECOMET
Contract manufacturer ยท Woburn, MA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1226425 (openFDA record; or search FDA's registration database)
- FEI number
- 3003018882
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Tecomet (FDA owner/operator no. 10031319)
- Registered address
- 170 New Boston Street, Woburn, MA 01801
- Contract listings
- 12 device listings, 10 product codes, first listed Mar 25, 2010
- 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 |
|---|---|---|---|---|---|
| DZL | Screw, Fixation, Intraosseous | Class II | Dental | Contract manufacturing | May 1, 2017 |
| EZX | Mesh, Surgical, Metal | Class II | General and plastic surgery | Contract manufacturing | Mar 25, 2010 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | Class II | Neurology | Contract manufacturing | Feb 26, 2013 |
| GXR | Cover, Burr Hole | Class II | Neurology | Contract manufacturing | Mar 25, 2010 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Mar 25, 2010 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Mar 25, 2010 |
| HWT | Template | Class I | Orthopedic | Contract manufacturing | Mar 1, 2013 |
| JEY | Plate, Bone | Class II | Dental | Contract manufacturing | Jan 25, 2013 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | Class II | Orthopedic | Contract manufacturing | Feb 1, 2013 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Jan 24, 2013 |