Cleared Traditional

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

K030519 · Hand Biomechanics Lab, Inc. · Orthopedic
Jun 2003
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K030519 is an FDA 510(k) clearance for the WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS, a Component, Traction, Invasive (Class II — Special Controls, product code JEC), submitted by Hand Biomechanics Lab, Inc. (Sacramento, US). The FDA issued a Cleared decision on June 10, 2003, 111 days after receiving the submission on February 19, 2003. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K030519 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2003
Decision Date June 10, 2003
Days to Decision 111 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JEC — Component, Traction, Invasive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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