FDA Registration
Active
🇺🇸 United States
MENISCAL ROOT REPAIR PACK WITH ULTRATAPE SUTURE
Reg #: 3010886696
·
FEI: 3010886696
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Smith & Nephew, Inc.
- Registration Number
- 3010886696
- FEI Number
- 3010886696
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3510 Winchester Rd
- City
- Memphis
- State
- TN
- ZIP
- 38118
- Country
- US
Regulatory Submissions
- 510(k) Number
- K933948
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 |
|---|---|---|---|---|---|
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2012-12-27 |
Proprietary Names
MENISCAL ROOT REPAIR PACK WITH ULTRATAPE SUTURE
MENISCAL ROOT REPAIR PACK W/ULTRABRAID
ENDOBUTTON, 4 MM X 12 MM
Endobutton, sterile, non-sterile
Establishment Types
Manufacture Medical Device