FDA Registration
Active
🇺🇸 United States
REDUX UNIVERSAL DRIVER HANDLE
Reg #: 3003604053
·
FEI: 3003604053
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SMITH & NEPHEW INC.
- Registration Number
- 3003604053
- FEI Number
- 3003604053
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ENDOSCOPY, 150 Minuteman Rd
- City
- ANDOVER
- State
- MA
- ZIP
- 01810
- Country
- US
Regulatory Submissions
- 510(k) Number
- K942079
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 |
|---|---|---|---|---|---|
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2013-01-09 |
Proprietary Names
REDUX UNIVERSAL DRIVER HANDLE
REDUX 2.4 MM DRIVER
REDUX 1.9 MM DRIVER
REDUX 2.3 MM DRIVER
REDUX 2.7 MM DRIVER
REDUX 3.4 MM DRIVER
REDUX BONE PIC
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility