Cleared Traditional

NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR

K030485 · Newmedical Technology, Inc. · Dental

Dec 2003

Decision

292d

Days

Class 2

Risk

About This 510(k) Submission

K030485 is an FDA 510(k) clearance for the NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR, a External Mandibular Fixator And/or Distractor (Class II — Special Controls, product code MQN), submitted by Newmedical Technology, Inc. (Waukesha, US). The FDA issued a Cleared decision on December 3, 2003, 292 days after receiving the submission on February 14, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number	K030485 FDA.gov
FDA Decision	Cleared 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