FDA Registration
Active
🇺🇸 United States
N8TIVE ACL Trans Tibial Center Guide
Reg #: 1643264
·
FEI: 1643264
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SMITH & NEPHEW INC.
- Registration Number
- 1643264
- FEI Number
- 1643264
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- ENDOSCOPY, 76 S. MERIDIAN AVE.
- City
- OKLAHOMA CITY
- State
- OK
- ZIP
- 73107
- Country
- US
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 |
|---|---|---|---|---|---|
| Brace, Drill | HXY | Class 1 | Orthopedic | No | 1978-02-22 |
Proprietary Names
N8TIVE ACL Trans Tibial Center Guide
SpeedLock HIP Drill Guide
HipSlide Slotted Cannula Insertion Guide
N8TIVE ACL Femoral Drill Guide
N8TIVE ACL Femoral Pin Guide
N8TIVE ACL Tibial Pin Guide
N8TIVE ACL Femoral Footprint Template
Establishment Types
Repack or Relabel Medical Device