Data / Medical devices / United States / Hand Biomechanics Lab, Inc.
Hand Biomechanics Lab, Inc.: FDA-registered device maker in Sacramento, CA, United States, 6 510(k) clearances
Hand Biomechanics Lab, Inc. is registered with the FDA (registration 2919128) in Sacramento, CA, United States. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 15, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2919128
- Address
- 77 Scripps Dr Ste 104, Sacramento, CA, United States, 95825
- Owner or operator
- HAND BIOMECHANICS LAB, INC. (2919128)
- Roles
- Manufacturer
- First device listed
- February 6, 2008
- Registered through
- 2026
- Brand names listed
- AGEE-WRISTJACK SYSTEM-STERILE, Agee Digit Widget®, Agee Digit Widget® External Fixation System, Agee PIP Fix, Agee TurnKey FCS®, Agee TurnKey FCS® External Fixation System, Agee WristJack®, Agee WristJack® External Fixation System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Arthroscope | HRX | 2 | Manufacturer | accessdata.fda.gov |
| Component, Traction, Invasive | JEC | 2 | Manufacturer | accessdata.fda.gov |
| Knife, Surgical | EMF | 1 | Manufacturer | accessdata.fda.gov |
| Pin, Fixation, Threaded | JDW | 2 | Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 15, 2025 | K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly | HRX | Substantially Equivalent | Hand Biomechanics Lab, Inc. | accessdata.fda.gov |
| November 14, 2022 | K222490 | HBL Blade Assembly | HRX | Substantially Equivalent | Hand Biomechanics Lab, Inc. | accessdata.fda.gov |
| October 22, 2018 | K181192 | PIP Fix | JEC | Substantially Equivalent | Hand Biomechanics Lab, Inc. | accessdata.fda.gov |
| January 9, 2008 | K072432 | F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE | JEC | Substantially Equivalent | Hand Biomechanics Lab, Inc. | accessdata.fda.gov |
| November 8, 1999 | K992970 | DIGIT WIDGET | JDW | Substantially Equivalent | Hand Biomechanics Lab, Inc. | accessdata.fda.gov |
| February 12, 1999 | K984442 | AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147 | JEC | Substantially Equivalent | Hand Biomechanics Lab, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 14, 2016 | 75255 | Class II | Terminated | Agee-WristJack Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use | A number of Agee WristJack Fracture Reduction Systems have been manufactured with a molded beam slightly larger than optimal. This may result in the surgeon experiencing difficulty fine-tuning the length (red) and radial/ulnar alignment (blue) adjustments on the device. | accessdata.fda.gov |
Compare with other makers
- All makers of Component, Traction, Invasive
- All makers of Knife, Surgical
- All makers of Arthroscope
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Pin, Fixation, Threaded
Updated October 15, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.