FDA Registration
Active
🇨🇷 Costa Rica
ULTRABUTTON BB BONE BLOCK ADJUSTABLE FIXATION DEVICE
Reg #: 3012358417
·
FEI: 3012358417
·
Expires 2025
Products
1
Proprietary Names
5
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
- K222971
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 |
|---|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2023-02-19 |
Proprietary Names
ULTRABUTTON BB BONE BLOCK ADJUSTABLE FIXATION DEVICE
ULTRABUTTON TIB ADJUSTABLE FIXATION DEVICE, MEDIUM
ULTRABUTTON TIB ADJUSTABLE FIXATION DEVICE, SMALL
ULTRABUTTON TIB ADJUSTABLE FIXATION DEVICE, LARGE
ULTRABUTTON QUAD ADJUSTABLE FIXATION DEVICE
Establishment Types
Manufacture Medical Device