FDA Registration
Active
🇺🇸 United States
LEGION Finned Tib Wedge Sz8 15mm Right
Reg #: 3007366790
·
FEI: 3007282753
·
Expires 2025
Products
2
Proprietary Names
42
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- Smith & Nephew, Inc.
- Registration Number
- 3007366790
- FEI Number
- 3007282753
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3303 E Holmes Rd
- City
- Memphis
- State
- TN
- ZIP
- 38118
- Country
- US
Regulatory Submissions
- 510(k) Number
- K180334
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2018-03-11 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2018-03-11 |
Proprietary Names
LEGION Finned Tib Wedge Sz8 15mm Right
LEGION Finned Tib Wedge Sz8 20mm Left
LEGION Finned Tib Wedge Sz5 20mm Right
LEGION Finned Tib Wedge Sz5 15mm Right
LEGION Finned Tib Wedge Sz4 10mm Right
LEGION Finned Tib Wedge Sz7 10mm Left
LEGION Finned Tib Wedge Sz5 15mm Left
LEGION Finned Tib Wedge Sz4 15mm Right
LEGION Finned Tib Wedge Sz6 20mm Right
LEGION Finned Tib Wedge Sz6 15mm Left
LEGION Finned Tib Wedge Sz7 15mm Left
LEGION Finned Tib Wedge Sz2 20mm Left
LEGION Finned Tib Wedge Sz2 15mm Right
LEGION Finned Tib Wedge Sz3 15mm Right
LEGION Finned Tib Wedge Sz8 20mm Right
LEGION Finned Tib Wedge Sz6 20mm Left
LEGION Finned Tib Wedge Sz2 10mm Right
LEGION Finned Tib Wedge Sz2 20mm Right
LEGION Finned Tib Wedge Sz2 10mm Left
LEGION Finned Tib Wedge Sz5 10mm Right
LEGION Finned Tib Wedge Sz4 10mm Left
LEGION Finned Tib Wedge Sz6 15mm Right
LEGION Finned Tib Wedge Sz8 15mm Left
LEGION Finned Tib Wedge Sz8 10mm Right
LEGION Finned Tib Wedge Sz3 10mm Right
LEGION Finned Tib Wedge Sz4 20mm Left
LEGION Finned Tib Wedge Sz 20mm Left
LEGION Finned Tib Wedge Sz8 10mm Left
LEGION Finned Tib Wedge Sz7 20mm Left
LEGION Finned Tib Wedge Sz2 15mm Left
LEGION Finned Tib Wedge Sz5 20mm Left
LEGION Finned Tib Wedge Sz6 10mm Right
LEGION Finned Tib Wedge Sz3 15mm Left
LEGION Finned Tib Wedge Sz7 10mm Right
LEGION Finned Tib Wedge Sz6 10mm Left
LEGION Finned Tib Wedge Sz4 20mm Right
LEGION Finned Tib Wedge Sz3 20mm Right
LEGION Finned Tib Wedge Sz4 15mm Left
LEGION Finned Tib Wedge Sz3 10mm Left
LEGION Finned Tib Wedge Sz5 10mm Left
LEGION Finned Tib Wedge Sz7 20mm Right
LEGION Finned Tib Wedge Sz7 15mm Right
Establishment Types
Manufacture Medical Device