Contract manufacturerARCH Medical & Aerospace - Woburn (Woburn, MA)MassachusettsOrthopedicGeneral and plastic surgeryClass II
ARCH Medical & Aerospace - Woburn
Contract manufacturer ยท Woburn, MA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3011765094 (openFDA record; or search FDA's registration database)
- FEI number
- 3011765094
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Arch Medical & Aerospace LLC dba M&K Engineering Inc. (FDA owner/operator no. 10086988)
- Registered address
- 166 NEW BOSTON ST, Woburn, MA 01801
- Contract listings
- 2 device listings, 3 product codes, first listed Dec 29, 2022
- 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 |
|---|---|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract manufacturing | Dec 29, 2022 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract manufacturing | Dec 29, 2022 |
| QAI | Powered Microneedle Device | Class II | General and plastic surgery | Contract manufacturing | Dec 29, 2022 |