DISTRAX— 510(k) K080542

Name: FDA 510(k) clearance K080542
Creator: U.S. Food and Drug Administration
Published: 2008-12-15

Substantially Equivalent

John W. King

FDA 510(k) clearance K080542 for DISTRAX, Substantially Equivalent on 2008-12-15. Applicant: John W. King. Device class: 2.

Clearance details

Applicant: John W. King
Product code: Code MQN
Device class: Class 2
Regulation: 21 CFR 872.4760
Advisory panel: Dental
Date received: 2008-02-27
Decision date: 2008-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQN

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K220050 — KLS Martin IPS Distraction2022-08-11
K183113 — DePuy Synthes Maxillofacial Portfolio - MR Conditional2019-03-13
K181504 — Stryker Pediatric Mandibular Distractor 22018-09-11
K162594 — Craniomaxillofacial Distraction System (CMFD)2017-05-08
K161470 — Internal Distraction - Sterile2016-12-01

Adverse events under product code MQN

product code MQN

Injury: 346
Total: 346

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.