Cleared Traditional

K051951 - CERAMENT BONE VOID FILLER (FDA 510(k) Clearance)

K051951 · Bonesupport AB · Orthopedic device

Sep 2005

Decision

72d

Days

Class 2

Risk

K051951 is an FDA 510(k) clearance for the CERAMENT BONE VOID FILLER. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).

Submitted by Bonesupport AB (Minneapolis, US). The FDA issued a Cleared decision on September 28, 2005, 72 days after receiving the submission on July 18, 2005.

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

Submission Details

510(k) Number	K051951 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 18, 2005
Decision Date	September 28, 2005
Days to Decision	72 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF