Cleared Traditional

K030485 - NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR

K030485 is an FDA 510(k) clearance for NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR, manufactured by Newmedical Technology, Inc.. The device is a Class 2 Dental device with product code MQN cleared through the Traditional 510(k) pathway after a 292-day FDA review.

K030485 · Newmedical Technology, Inc. · Dental device
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Dec 2003
Decision
292d
Days
Class 2
Risk

K030485 is an FDA 510(k) clearance for the NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR. Classified as External Mandibular Fixator And/or Distractor (product code MQN), Class II - Special Controls.

Submitted by Newmedical Technology, Inc. (Waukesha, US). The FDA issued a Cleared decision on December 3, 2003 after a review of 292 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Newmedical Technology, Inc. devices

FDA 510(k) Submission Details - K030485

510(k) Number K030485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2003
Decision Date December 03, 2003
Days to Decision 292 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 127d · This submission: 292d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQN Device Classification - Class 2, Special Controls

Product Code MQN External Mandibular Fixator And/or Distractor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - MQN External Mandibular Fixator And/or Distractor

All 50
Devices cleared under the same product code (MQN) and FDA review panel - the closest regulatory comparables to K030485.
SYNTHES MANDIBLE EXTERNAL FIXATOR
K040169 · Synthes (Usa) · Apr 2004
SYNTHES EXTERNAL MIDFACE DISTRACTOR
K040083 · Synthes (Usa) · Mar 2004
KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM
K034027 · KLS-Martin L.P. · Feb 2004
OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM
K031708 · Osteomed LP · Nov 2003
KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II
K032442 · KLS-Martin L.P. · Oct 2003
SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES
K033065 · Synthes (Usa) · Oct 2003