Cleared Traditional

K113871 - PRO-DENSE BONE GRAFT SUBSTITUTE (FDA 510(k) Clearance)

K113871 · Wrightmedicaltechnologyinc · Orthopedic device

Mar 2013

Decision

451d

Days

Class 2

Risk

K113871 is an FDA 510(k) clearance for the PRO-DENSE 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 25, 2013, 451 days after receiving the submission on December 30, 2011.

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

Submission Details

510(k) Number	K113871 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 30, 2011
Decision Date	March 25, 2013
Days to Decision	451 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF