Cleared Traditional

K020895 - ALLOMATRIX MODEL# 86 (FDA 510(k) Clearance)

K020895 · Wrightmedicaltechnologyinc · Orthopedic device

Mar 2004

Decision

717d

Days

Class 2

Risk

K020895 is an FDA 510(k) clearance for the ALLOMATRIX MODEL# 86. 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 March 5, 2004, 717 days after receiving the submission on March 19, 2002.

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

Submission Details

510(k) Number	K020895 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 19, 2002
Decision Date	March 05, 2004
Days to Decision	717 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF