FDA Registration
Active
🇨🇷 Costa Rica
KIT 5.5mm FP SUT ANC SL ACH TENDON RE
Reg #: 3012358417
·
FEI: 3012358417
·
Expires 2025
Products
1
Proprietary Names
8
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
- K123579
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 | 2013-07-03 |
Proprietary Names
KIT 5.5mm FP SUT ANC SL ACH TENDON RE
DRILL 4.5MM FOR 5.5MM ANCHOR SL-PLUS
FOOTPRINT ULR 5.5 PK SUT SL
DRILL 4MM FOR 4.5MM ANCHOR SL-PLUS
FOOTPRINT Ultra PK Suture Anchor 4.5mm SL
FOOTPRINT Ultra PK Suture Anchor 5.5mm SL
FOOTPRINT ULR 4.5 PK SUT SL
KIT, 4.5mm FP SUT AN CSL, ACH TENDON RE
Establishment Types
Manufacture Medical Device