Medical Device Manufacturer · US , Sacramento , CA

Hand Biomechanics Lab, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1994

Recent clearances: TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly, HBL Blade Assembly, PIP Fix

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hand Biomechanics Lab, Inc. Orthopedic ✕

9 devices

1-9 of 9

Cleared Oct 15, 2025

TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly

Orthopedic · 107d

Cleared Nov 14, 2022

HBL Blade Assembly

Orthopedic · 89d

Cleared Oct 22, 2018

Orthopedic · 171d

Cleared Jan 09, 2008

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

Orthopedic · 133d

Cleared Nov 05, 2003

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

Orthopedic · 36d

Cleared Jun 10, 2003

WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS...

Orthopedic · 111d

Cleared Nov 08, 1999

Orthopedic · 66d

Cleared Feb 12, 1999

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

Orthopedic · 60d

Cleared Dec 22, 1994

AGEE-WRISTJACK PRE-DRILL KIT

Orthopedic · 184d