Cleared Traditional

K032288 - VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL (FDA 510(k) Clearance)

K032288 · Orthovita, Inc. · Orthopedic device

Dec 2003

Decision

148d

Days

Class 2

Risk

K032288 is an FDA 510(k) clearance for the VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL. 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 December 19, 2003, 148 days after receiving the submission on July 24, 2003.

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

Submission Details

510(k) Number	K032288 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 24, 2003
Decision Date	December 19, 2003
Days to Decision	148 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF