Cleared Traditional

K022828 - OSTEOSET DBM PELLETS, MODEL 8600-48XX (FDA 510(k) Clearance)

K022828 · Wrightmedicaltechnologyinc · Orthopedic device

Apr 2004

Decision

585d

Days

Class 2

Risk

K022828 is an FDA 510(k) clearance for the OSTEOSET DBM PELLETS, MODEL 8600-48XX. 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 April 2, 2004, 585 days after receiving the submission on August 26, 2002.

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

Submission Details

510(k) Number	K022828 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 26, 2002
Decision Date	April 02, 2004
Days to Decision	585 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF