Cleared Traditional

K130703 - VIVORTE BVF
(FDA 510(k) Clearance)

K130703 · Vivorte, Inc. · Orthopedic

Sep 2013

Decision

181d

Days

Class 2

Risk

K130703 is an FDA 510(k) clearance for the VIVORTE BVF. This device is classified as a Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) (Class II — Special Controls, product code MBP).

Submitted by Vivorte, Inc. (Fort Wayne, US). The FDA issued a Cleared decision on September 12, 2013, 181 days after receiving the submission on March 15, 2013.

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

Submission Details

510(k) Number	K130703 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 15, 2013
Decision Date	September 12, 2013
Days to Decision	181 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF