Cleared Special

K024336 - MIIG II BONE GRAFT SUBSTITUTE (FDA 510(k) Clearance)

K024336 · Wrightmedicaltechnologyinc · Orthopedic device

Mar 2003

Decision

67d

Days

Class 2

Risk

K024336 is an FDA 510(k) clearance for the MIIG II BONE GRAFT SUBSTITUTE. 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 4, 2003, 67 days after receiving the submission on December 27, 2002.

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

Submission Details

510(k) Number	K024336 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 27, 2002
Decision Date	March 04, 2003
Days to Decision	67 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF