Cleared Traditional

K090871 - CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12 (FDA 510(k) Clearance)

K090871 · Bonesupport AB · Orthopedic device

Sep 2009

Decision

158d

Days

Class 2

Risk

K090871 is an FDA 510(k) clearance for the CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).

Submitted by Bonesupport AB (Lund, SE). The FDA issued a Cleared decision on September 4, 2009, 158 days after receiving the submission on March 30, 2009.

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

Submission Details

510(k) Number	K090871 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 30, 2009
Decision Date	September 04, 2009
Days to Decision	158 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF