FDA Registration
Active
🇺🇸 United States
OsteoFab Patient Specific Cranial Device
Reg #: 3009582362
·
FEI: 3009582362
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- OXFORD PERFORMANCE MATERIALS, INC.
- Registration Number
- 3009582362
- FEI Number
- 3009582362
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 30 South Satellite Road
- City
- South Windsor
- State
- CT
- ZIP
- 06074
- Country
- US
Regulatory Submissions
- 510(k) Number
- K180064
Owner / Operator
- Firm Name
- Oxford Performance Materials, Inc.
- Operator Number
- 10043473
- Address
- 30 South Satellite Road
- City
- South Windsor
- State
- CT
- Postal Code
- 06074
- Country
- US
- Correspondent
- James Porteus
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Cranioplasty, Preformed, Non-Alterable | GXN | Class 2 | Neurology | No | 2019-05-16 |
Proprietary Names
OsteoFab Patient Specific Cranial Device
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device