Cleared Traditional

K041168 - ALLOMATRIX PUTTY (FDA 510(k) Clearance)

K041168 · Wrightmedicaltechnologyinc · Orthopedic device

Aug 2004

Decision

90d

Days

Class 2

Risk

K041168 is an FDA 510(k) clearance for the ALLOMATRIX PUTTY. 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 2, 2004, 90 days after receiving the submission on May 4, 2004.

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

Submission Details

510(k) Number	K041168 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 04, 2004
Decision Date	August 02, 2004
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF