Cleared Traditional

K061493 - APEX PINS (FDA 510(k) Clearance)

K061493 · Stryker Howmedica Osteonics · Orthopedic device

Jul 2006

Decision

37d

Days

Class 2

Risk

K061493 is an FDA 510(k) clearance for the APEX PINS. This device is classified as a Pin, Fixation, Threaded (Class II - Special Controls, product code JDW).

Submitted by Stryker Howmedica Osteonics (Mahwah, US). The FDA issued a Cleared decision on July 7, 2006, 37 days after receiving the submission on May 31, 2006.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K061493 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 31, 2006
Decision Date	July 07, 2006
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF