Cleared Traditional

K032409 - VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER (FDA 510(k) Clearance)

K032409 · Orthovita, Inc. · Orthopedic device

Aug 2003

Decision

25d

Days

Class 2

Risk

K032409 is an FDA 510(k) clearance for the VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER. 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 August 29, 2003, 25 days after receiving the submission on August 4, 2003.

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

Submission Details

510(k) Number	K032409 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 04, 2003
Decision Date	August 29, 2003
Days to Decision	25 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF