Cleared Traditional

K062353 - MOZAIK BONE REGENERATION MATRIX - PUTTY (FDA 510(k) Clearance)

K062353 · Integra LifeSciences Corporation · Orthopedic device

Dec 2006

Decision

131d

Days

Class 2

Risk

K062353 is an FDA 510(k) clearance for the MOZAIK BONE REGENERATION MATRIX - PUTTY. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).

Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on December 20, 2006, 131 days after receiving the submission on August 11, 2006.

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

Submission Details

510(k) Number	K062353 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 11, 2006
Decision Date	December 20, 2006
Days to Decision	131 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF