Cleared Traditional

INTRAORAL MANDIBULAR DISTRACTION SYSTEM

K013618 · Osteomed Corp. · Dental
Aug 2002
Decision
282d
Days
Class 2
Risk

About This 510(k) Submission

K013618 is an FDA 510(k) clearance for the INTRAORAL MANDIBULAR DISTRACTION SYSTEM, a External Mandibular Fixator And/or Distractor (Class II — Special Controls, product code MQN), submitted by Osteomed Corp. (Addison, US). The FDA issued a Cleared decision on August 14, 2002, 282 days after receiving the submission on November 5, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number K013618 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2001
Decision Date August 14, 2002
Days to Decision 282 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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