Cleared Traditional

K040064 - NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR
(FDA 510(k) Clearance)

K040064 · Newmedical Technology, Inc. · Orthopedic

Mar 2004

Decision

70d

Days

Class 2

Risk

K040064 is an FDA 510(k) clearance for the NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR. This device is classified as a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT).

Submitted by Newmedical Technology, Inc. (Waukesha, US). The FDA issued a Cleared decision on March 23, 2004, 70 days after receiving the submission on January 13, 2004.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K040064 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 13, 2004
Decision Date	March 23, 2004
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KTT — Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3030