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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 Dec 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 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 3, 2003
Date Received
Feb 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
510(k)

Other clearances by Newmedical Technology, Inc.

  • K041704 — NEWGEL AND NEWGEL PLUS E (Oct 17, 2005)
  • K040064 — NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR (Mar 23, 2004)

Other clearances for product code MQN

  • K220050 — KLS Martin IPS Distraction (Aug 11, 2022)
  • K183113 — DePuy Synthes Maxillofacial Portfolio - MR Conditional (Mar 13, 2019)
  • K181504 — Stryker Pediatric Mandibular Distractor 2 (Sep 11, 2018)
  • K162594 — Craniomaxillofacial Distraction System (CMFD) (May 8, 2017)
  • K161470 — Internal Distraction - Sterile (Dec 1, 2016)
  • K143285 — Mandible External Fixator - MR Conditional (May 28, 2015)
  • K133398 — STRYKER PEDIATRIC MANDIBLE DISTRACTOR (Mar 20, 2014)
  • K121502 — SYNTHES CURVILINEAR DISTRACTION SYSTEM (Aug 23, 2012)
  • K080458 — MIS CREST WIDENER (Dec 17, 2008)
  • K080542 — DISTRAX (Dec 15, 2008)

FDA data resources

Source: FDA 510(k) database entry for K030485. Report a data issue: hello@regdatalab.com.