FDA.reportPublic FDA data

HAND BIOMECHANICS LAB, INC.

Matched from indexed company URL: Hand Biomechanics Lab Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29191282919128HAND BIOMECHANICS LAB, INC.1N2026-01-0177 Scripps Dr Ste 104 SACRAMENTO CA US 95825

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00861994000205Agee WristJack® - Fracture Reduction System. Fracture reduction and external fixation for treatment of distal radius fractures.800-522-5778info@handbiolab.com
00861994000212Agee Digit Widget® - External fixation system for treatment of PIP joint flexion contractures.800-522-5778info@handbiolab.com
00861994000229Agee TurnKey FCS® - External fixation system for acute dorsal fracture dislocations of the PIP joint.800-522-5778info@handbiolab.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
388481815942894K992970DIGIT WIDGETJDW1999-11-08
388481981262676K984442AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147JEC1999-02-12
388481393236334K252020TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHRX2025-10-15
388481562383190K222490HBL Blade AssemblyHRX2022-11-14
388481081390876K181192PIP FixJEC2018-10-22
388481753486107K072432F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILEJEC2008-01-09
388481773667398K030519WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNSJEC2003-06-10
388481561467899

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JEC42018-10-22
HRX22025-10-15
JDW11999-11-08

PMN#

PIP Fix

2018-10-22

Hand Biomechanics Lab, Inc.

GUDID#