FDA Registration
Active
🇺🇸 United States
TurnKey FCS
Reg #: 2919128
·
FEI: 2919128
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HAND BIOMECHANICS LAB, INC.
- Registration Number
- 2919128
- FEI Number
- 2919128
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 77 Scripps Dr Ste 104
- City
- SACRAMENTO
- State
- CA
- ZIP
- 95825
- Country
- US
Regulatory Submissions
- 510(k) Number
- K072432
Owner / Operator
- Firm Name
- HAND BIOMECHANICS LAB, INC.
- Operator Number
- 2919128
- Address
- 77 SCRIPPS DR., SUITE 104, --
- City
- Sacramento
- State
- CA
- Postal Code
- 95825
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Component, Traction, Invasive | JEC | Class 2 | Orthopedic | No | 2008-02-06 |
Proprietary Names
TurnKey FCS
TurnKey FCS®
Agee TurnKey FCS®
Agee TurnKey FCS® External Fixation System
TurnKey FCS® External Fixation System
Establishment Types
Manufacture Medical Device