FDA Registration
Active
🇨🇷 Costa Rica
ULTRA FAST-FIX ASSEMBLY - CURVED
Reg #: 3012358417
·
FEI: 3012358417
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Arthrocare Corporation
- Registration Number
- 3012358417
- FEI Number
- 3012358417
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- B32.1, St2, Zona Franca Coyol
- City
- Coyol Alajuela
- Country
- CR
Regulatory Submissions
- 510(k) Number
- K121861
Owner / Operator
- Firm Name
- Smith & Nephew, Inc.
- Operator Number
- 1020279
- Address
- 2875 Railroad Street
- City
- Pittsburgh
- State
- PA
- Postal Code
- 15222
- Country
- US
- Correspondent
- Lisa Ewing
US Agent
- Business Name
- Smith & Nephew, Inc.
- Contact Name
- Lisa Ewing
- Address
- 2875 Railroad St
- City
- Pittsburgh
- State
- PA
- ZIP
- 15222
- Country
- US
- [email protected]
- Phone
- 412 4199765
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2019-04-25 |
Proprietary Names
ULTRA FAST-FIX ASSEMBLY - CURVED
ULTRA FAST-FIX ASSMBLY - REVERSE CURVED
ULTRA FAST-FIX ASSEMBLY - STRAIGHT
FAST-FIX 360 CURVED NDL DELIVERY SYSTEM
FAST-FIX 360 REVERSE CURVE NDL DELIVERY SYSTEM
FAST-FIX 360 CURVED MENISCAL REPAIR SYSTEM
FAST-FIX 360 STRAIGHT NDL DELIVERY SYSTEM
FAST-FIX 360 STRAIGHT MENISCAL REPAIR SYSTEM
FAST-FIX 360 REVERSED CURVE MENISCAL REPAIR SYSTEM
Establishment Types
Manufacture Medical Device