Cleared Traditional

K072184 - VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE (FDA 510(k) Clearance)

K072184 · Orthovita, Inc. · Orthopedic device

Sep 2007

Decision

43d

Days

Class 2

Risk

K072184 is an FDA 510(k) clearance for the VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).

Submitted by Orthovita, Inc. (Malver, US). The FDA issued a Cleared decision on September 18, 2007, 43 days after receiving the submission on August 6, 2007.

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

Submission Details

510(k) Number	K072184 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 06, 2007
Decision Date	September 18, 2007
Days to Decision	43 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF