Cleared Traditional

K060061 - STRYKER INJECTABLE CEMENT (FDA 510(k) Clearance)

K060061 · Stryker Corp. · Orthopedic device

Mar 2006

Decision

51d

Days

Class 2

Risk

K060061 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 Corp. (Kalamazoo, US). The FDA issued a Cleared decision on March 1, 2006, 51 days after receiving the submission on January 9, 2006.

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

Submission Details

510(k) Number	K060061 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 09, 2006
Decision Date	March 01, 2006
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF