Cleared Traditional

K043514 - ALLOGRAN-N-BONE VOID FILLER
(FDA 510(k) Clearance)

K043514 · Biocomposites, Ltd. · Orthopedic

Jan 2005

Decision

32d

Days

Class 2

Risk

K043514 is an FDA 510(k) clearance for the ALLOGRAN-N-BONE VOID FILLER. This device is classified as a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV).

Submitted by Biocomposites, Ltd. (Keele, GB). The FDA issued a Cleared decision on January 21, 2005, 32 days after receiving the submission on December 20, 2004.

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

Submission Details

510(k) Number	K043514 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 2004
Decision Date	January 21, 2005
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF