FDA Registration
Active
🇨🇷 Costa Rica
8 X 25 MM BIORCI SCREW
Reg #: 3012358417
·
FEI: 3012358417
·
Expires 2025
Products
1
Proprietary Names
13
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
- K992396
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 |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-01-15 |
Proprietary Names
8 X 25 MM BIORCI SCREW
8 X 30 MM BIORCI SCREW
9 X 35 MM BIORCI SCREW
L SCREW STARTER
9 X 25 MM BIORCI SCREW
7 MM X 25 MM REVERSE THREAD BIORCI SCREW
8 X 35 MM BIORCI SCREW
7 X 25 MM BIORCI SCREW
9 X 30 MM BIORCI SCREW
7 X 25 MM BIORCI SCREW WITH AN 8 MM HEAD
10 X 30 MM BIORCI SCREW
7 X 30 MM BIORCI SCREW
BIORCI SCREW, Sterile
Establishment Types
Manufacture Medical Device