Medical Device Manufacturer · US , Sacramento , CA

Hand Biomechanics Lab, Inc.

9 submissions · 9 cleared · Since 1994

Total

Cleared

Denied

Hand Biomechanics Lab, Inc. — FDA 510(k) Submissions

Hand Biomechanics Lab, Inc. has submitted 9 FDA 510(k) premarket notifications since 1994, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Component, Traction, Invasive, Arthroscope, Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Bit, Drill, Pin, Fixation, Threaded . Use the specialty filter in the sidebar to narrow results.

9 devices

1–9 of 9

TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly

K252020 · HRX Arthroscope · Orthopedic

Oct 2025 107d

HBL Blade Assembly

K222490 · HRX Arthroscope · Orthopedic

Nov 2022 89d

PIP Fix

K181192 · JEC Component, Traction,... · Orthopedic

Oct 2018 171d

F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE

K072432 · JEC Component, Traction,... · Orthopedic

Jan 2008 133d

WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS

K033112 · KTT Appliance, Fixation,... · Orthopedic

Nov 2003 36d

WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS

K030519 · JEC Component, Traction,... · Orthopedic

Jun 2003 111d

DIGIT WIDGET

K992970 · JDW Pin, Fixation, Threaded · Orthopedic

Nov 1999 66d

AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147

K984442 · JEC Component, Traction,... · Orthopedic

Feb 1999 60d

AGEE-WRISTJACK PRE-DRILL KIT

K942906 · HTW Bit, Drill · Orthopedic

Dec 1994 184d

Data Source

FDA 510(k) public files . 174,402 total devices indexed.

Hand Biomechanics Lab, Inc.

Hand Biomechanics Lab, Inc. — FDA 510(k) Submissions

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