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510(k) K080458

MIS CREST WIDENER by Mis - Implant Technologies , Ltd. — Product Code MQN

K080458 is an FDA 510(k) premarket notification submitted by Mis - Implant Technologies , Ltd. for the device "MIS CREST WIDENER". The FDA issued a decision of Substantially Equivalent on December 17, 2008. The device falls under product code MQN (External Mandibular Fixator And/Or Distractor), a Class II device regulated under 21 CFR 872.4760. Mis - Implant Technologies , Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2008
Date Received
February 20, 2008
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 by Mis - Implant Technologies , Ltd.

  • K103089 — SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS (September 15, 2011)
  • K040807 — MIS DENTAL IMPLANT SYSTEM (June 9, 2004)

Other clearances for product code MQN

  • K220050 — KLS Martin IPS Distraction (August 11, 2022)
  • 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)
  • K080542 — DISTRAX (December 15, 2008)
  • K080153 — SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM (May 14, 2008)

FDA data resources