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510(k) K062572

CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE by Custom Scientific — Product Code MQN

K062572 is an FDA 510(k) premarket notification submitted by Custom Scientific for the device "CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE". The FDA issued a decision of Substantially Equivalent on May 11, 2007. The device falls under product code MQN (External Mandibular Fixator And/Or Distractor), a Class II device regulated under 21 CFR 872.4760.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2007
Date Received
August 31, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
External Mandibular Fixator And/Or Distractor
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

Other clearances for product code MQN

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  • K183113 — DePuy Synthes Maxillofacial Portfolio - MR Conditional (March 13, 2019)
  • K181504 — Stryker Pediatric Mandibular Distractor 2 (September 11, 2018)
  • K162594 — Craniomaxillofacial Distraction System (CMFD) (May 8, 2017)
  • K161470 — Internal Distraction - Sterile (December 1, 2016)
  • K143285 — Mandible External Fixator - MR Conditional (May 28, 2015)
  • K133398 — STRYKER PEDIATRIC MANDIBLE DISTRACTOR (March 20, 2014)
  • K121502 — SYNTHES CURVILINEAR DISTRACTION SYSTEM (August 23, 2012)
  • K080458 — MIS CREST WIDENER (December 17, 2008)
  • K080542 — DISTRAX (December 15, 2008)

FDA data resources