Hand Biomechanics Lab Inc
Sacramento, CA, US
HAND BIOMECHANICS LAB, INC. appears in FDA device records in Sacramento, CA. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Hand Biomechanics Lab Inc between 1994 and 2025. The busiest year on record is 1999, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1999 | 2 |
| 2003 | 2 |
| 2008 | 1 |
| 2018 | 1 |
| 2022 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly | HRX | Substantially Equivalent | |
| K222490 | HBL Blade Assembly | HRX | Substantially Equivalent | |
| K181192 | PIP Fix | JEC | Substantially Equivalent | |
| K072432 | F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE | JEC | Substantially Equivalent | |
| K033112 | WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS | KTT | Substantially Equivalent | |
| K030519 | WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS | JEC | Substantially Equivalent | |
| K992970 | DIGIT WIDGET | JDW | Substantially Equivalent | |
| K984442 | AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147 | JEC | Substantially Equivalent | |
| K942906 | AGEE-WRISTJACK PRE-DRILL KIT | HTW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2919128 | 2919128 | HAND BIOMECHANICS LAB, INC. | 77 Scripps Dr Ste 104, SACRAMENTO, CA 95825 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0136-2017 | 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 system used for a trauma related surgery The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboard shelf box. Orthopedic:The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. | 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. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Hand Biomechanics Lab Inc edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain