Cleared Traditional

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

K072432 · Hand Biomechanics Lab, Inc. · Orthopedic
Jan 2008
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K072432 is an FDA 510(k) clearance for the F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE, 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 January 9, 2008, 133 days after receiving the submission on August 29, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K072432 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2007
Decision Date January 09, 2008
Days to Decision 133 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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