Cleared Traditional

STRYKER PEDIATRIC MANDIBLE DISTRACTOR

K133398 · Stryker · Dental
Mar 2014
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K133398 is an FDA 510(k) clearance for the STRYKER PEDIATRIC MANDIBLE DISTRACTOR, a External Mandibular Fixator And/or Distractor (Class II — Special Controls, product code MQN), submitted by Stryker (Portage, US). The FDA issued a Cleared decision on March 20, 2014, 134 days after receiving the submission on November 6, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number K133398 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2013
Decision Date March 20, 2014
Days to Decision 134 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code MQN — External Mandibular Fixator And/or Distractor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4760

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