Cleared Traditional

K083232 - MODIFICATION TO:MICROFUSE BONE VOID FILLER (FDA 510(k) Clearance)

K083232 · Globus Medical, Inc. · Orthopedic device

Dec 2008

Decision

51d

Days

Class 2

Risk

K083232 is an FDA 510(k) clearance for the MODIFICATION TO:MICROFUSE BONE VOID FILLER. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on December 24, 2008, 51 days after receiving the submission on November 3, 2008.

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

Submission Details

510(k) Number	K083232 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 03, 2008
Decision Date	December 24, 2008
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF