FDA Registration
Active
🇺🇸 United States
HemiCap GRS Glenoid Resurfacing System
Reg #: 3004154314
·
FEI: 3004154314
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ARTHROSURFACE, INC.
- Registration Number
- 3004154314
- FEI Number
- 3004154314
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 319 Manley St
- City
- W Bridgewater
- State
- MA
- ZIP
- 02379
- Country
- US
Regulatory Submissions
- 510(k) Number
- K091196
Owner / Operator
- Firm Name
- Arthrosurface, Inc.
- Operator Number
- 9058162
- Address
- 319 Manley St, --
- City
- W Bridgewater
- State
- MA
- Postal Code
- 02379
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2011-11-21 |
Proprietary Names
HemiCap GRS Glenoid Resurfacing System
Establishment Types
Manufacture Medical Device