Contract manufacturerContract sterilizerOSTEOMED (Addison, TX)TexasDentalNeurologyRadiologyClass II
OSTEOMED
Contract manufacturer and sterilizer · Addison, TX
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2027754 (openFDA record; or search FDA's registration database)
- FEI number
- 2027754
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Specification developer; Manufacturer for export only; Manufacturer; Contract manufacturer; Repackager or relabeler; Contract sterilizer
- Owner or operator
- OSTEOMED (FDA owner/operator no. 9000613)
- Registered address
- 3885 Arapaho Rd, Addison, TX 75001
- Contract listings
- 5 device listings, 4 product codes, first listed Apr 2, 2026
- 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 |
|---|---|---|---|---|---|
| DZJ | Driver, Wire, And Bone Drill, Manual | Class II | Dental | Contract manufacturing | Apr 2, 2026 |
| DZJ | Driver, Wire, And Bone Drill, Manual | Class II | Dental | Contract sterilization | Apr 2, 2026 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | Class II | Neurology | Contract manufacturing | Apr 2, 2026 |
| JEY | Plate, Bone | Class II | Dental | Contract manufacturing | Apr 2, 2026 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | Contract manufacturing | Apr 2, 2026 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | Contract sterilization | Apr 2, 2026 |