Cleared Traditional

K051603 - STRYKER INJECTABLE CEMENT (FDA 510(k) Clearance)

K051603 · Stryker Leibinger Micro Implants · Orthopedic device

Dec 2005

Decision

198d

Days

Class 2

Risk

K051603 is an FDA 510(k) clearance for the STRYKER INJECTABLE CEMENT. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).

Submitted by Stryker Leibinger Micro Implants (Portage, US). The FDA issued a Cleared decision on December 30, 2005, 198 days after receiving the submission on June 15, 2005.

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

Submission Details

510(k) Number	K051603 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 15, 2005
Decision Date	December 30, 2005
Days to Decision	198 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF