FDA Registration
Active
🇨🇷 Costa Rica
TRI-POINT BULLET
Reg #: 3012358417
·
FEI: 3012358417
·
Expires 2025
Products
1
Proprietary Names
6
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
- K832277
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 |
|---|---|---|---|---|---|
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2013-01-09 |
Proprietary Names
TRI-POINT BULLET
STOP DRILL PCL 11MM
MULTI-TRAC PCL System; Multi-Trac PCL Drill Guide System
AIMER REAR ENTRY-LEFT
AIMER REAR ENTRY RIGHT-ACL
REAR ENTRY INTRODUCER
Establishment Types
Manufacture Medical Device