Cleared Traditional

K130977 - SIGNIFY BIOACTIVE (FDA 510(k) Clearance)

K130977 · Globus Medical, Inc. · Orthopedic device

Dec 2013

Decision

259d

Days

Class 2

Risk

K130977 is an FDA 510(k) clearance for the SIGNIFY BIOACTIVE. 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, 2013, 259 days after receiving the submission on April 9, 2013.

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

Submission Details

510(k) Number	K130977 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 09, 2013
Decision Date	December 24, 2013
Days to Decision	259 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF