Cleared Traditional

K133678 - CONFIRM BIOACTIVE (FDA 510(k) Clearance)

K133678 · Globus Medical, Inc. · Orthopedic device

Aug 2014

Decision

270d

Days

Class 2

Risk

K133678 is an FDA 510(k) clearance for the CONFIRM 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 August 26, 2014, 270 days after receiving the submission on November 29, 2013.

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

Submission Details

510(k) Number	K133678 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 29, 2013
Decision Date	August 26, 2014
Days to Decision	270 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF