Cleared Traditional

K083270 - WMT COMPOSITE DBM (FDA 510(k) Clearance)

K083270 · Wrightmedicaltechnologyinc · Orthopedic device

Aug 2009

Decision

294d

Days

Class 2

Risk

K083270 is an FDA 510(k) clearance for the WMT COMPOSITE DBM. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on August 27, 2009, 294 days after receiving the submission on November 6, 2008.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number	K083270 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 06, 2008
Decision Date	August 27, 2009
Days to Decision	294 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF