FDA Registration
Active
🇺🇸 United States
HAND BIOMECHANICS LAB, INC.
Reg #: 2919128
·
FEI: 2919128
·
Expires 2026
Products
5
Proprietary Names
24
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- HAND BIOMECHANICS LAB, INC.
- Registration Number
- 2919128
- FEI Number
- 2919128
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 77 Scripps Dr Ste 104
- City
- SACRAMENTO
- State
- CA
- ZIP
- 95825
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181192
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 | 2019-01-07 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2022-11-15 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2026-02-09 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2026-02-09 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2008-02-06 |
Proprietary Names
PIP Fix
Agee PIP Fix
PIP Fix
PIP Fix® External Fixation System
Disposable Blade Assembly
ECTR Disposable Blade Assembly
Endoscopic Carpal Tunnel Release Blade Assembly
TurnKey FCS
Agee TurnKey FCS® External Fixation System
Agee TurnKey FCS®
TurnKey FCS® External Fixation System
TurnKey FCS®
AGEE-WRISTJACK SYSTEM-STERILE
Agee WristJack® External Fixation System, Sterile
Agee WristJack® External Fixation System
Agee WristJack®
Agee-WristJack® Fracture Reduction System, Sterile
WristJack®
TunnelVision System
DIGIT WIDGET
Digit Widget®
Digit Widget® External Fixation System
Agee Digit Widget®
Agee Digit Widget® External Fixation System
Establishment Types
Manufacture Medical Device