Cleared Traditional

PIP Fix

K181192 · Hand Biomechanics Lab, Inc. · Orthopedic
Oct 2018
Decision
171d
Days
Class 2
Risk

About This 510(k) Submission

K181192 is an FDA 510(k) clearance for the PIP Fix, 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 October 22, 2018, 171 days after receiving the submission on May 4, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K181192 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 2018
Decision Date October 22, 2018
Days to Decision 171 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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