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510(k) K030485

NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR by Newmedical Technology, Inc. — Product Code MQN

K030485 is an FDA 510(k) premarket notification submitted by Newmedical Technology, Inc. for the device "NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR". The FDA issued a decision of Substantially Equivalent on December 3, 2003. The device falls under product code MQN (External Mandibular Fixator And/Or Distractor), a Class II device regulated under 21 CFR 872.4760. Newmedical Technology, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2003
Date Received
February 14, 2003
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 Newmedical Technology, Inc.

  • K041704 — NEWGEL AND NEWGEL PLUS E (October 17, 2005)
  • K040064 — NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR (March 23, 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)
  • K080458 — MIS CREST WIDENER (December 17, 2008)
  • K080542 — DISTRAX (December 15, 2008)

FDA data resources