Cleared Traditional

K071187 - MICROFUSE BONE VOID FILLER (FDA 510(k) Clearance)

K071187 · Globus Medical, Inc. · Orthopedic device

Dec 2007

Decision

234d

Days

Class 2

Risk

K071187 is an FDA 510(k) clearance for the 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 20, 2007, 234 days after receiving the submission on April 30, 2007.

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

Submission Details

510(k) Number	K071187 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 30, 2007
Decision Date	December 20, 2007
Days to Decision	234 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF