Cleared Traditional

K041421 - NAME BONE VOID FILLER (FDA 510(k) Clearance)

K041421 · Stryker Biotech · Orthopedic device

Aug 2004

Decision

90d

Days

Class 2

Risk

K041421 is an FDA 510(k) clearance for the NAME BONE VOID FILLER. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).

Submitted by Stryker Biotech (Hopkinton, US). The FDA issued a Cleared decision on August 26, 2004, 90 days after receiving the submission on May 28, 2004.

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

Submission Details

510(k) Number	K041421 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 28, 2004
Decision Date	August 26, 2004
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF