Cleared Traditional

K033258 - BONESAVE BONE VOID FILLER (FDA 510(k) Clearance)

K033258 · Howmedica Osteonics · Orthopedic device

Mar 2004

Decision

152d

Days

Class 2

Risk

K033258 is an FDA 510(k) clearance for the BONESAVE BONE VOID FILLER. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).

Submitted by Howmedica Osteonics (Allendale, US). The FDA issued a Cleared decision on March 9, 2004, 152 days after receiving the submission on October 9, 2003.

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

Submission Details

510(k) Number	K033258 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 09, 2003
Decision Date	March 09, 2004
Days to Decision	152 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF