FDA.reportPublic FDA data

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

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#