Cleared Traditional

K003954 - STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT (FDA 510(k) Clearance)

K003954 · Biocomposites, Ltd. · Orthopedic device

Jul 2001

Decision

203d

Days

Class 2

Risk

K003954 is an FDA 510(k) clearance for the STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).

Submitted by Biocomposites, Ltd. (Stoke On Trent, GB). The FDA issued a Cleared decision on July 12, 2001, 203 days after receiving the submission on December 21, 2000.

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

Submission Details

510(k) Number	K003954 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 21, 2000
Decision Date	July 12, 2001
Days to Decision	203 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF