Cleared Traditional

K012270 - STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM (FDA 510(k) Clearance)

K012270 · Stryker Endoscopy · Orthopedic device

Sep 2001

Decision

71d

Days

Class 2

Risk

K012270 is an FDA 510(k) clearance for the STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM. This device is classified as a Pin, Fixation, Threaded (Class II - Special Controls, product code JDW).

Submitted by Stryker Endoscopy (Santa Clara, US). The FDA issued a Cleared decision on September 28, 2001, 71 days after receiving the submission on July 19, 2001.

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

Submission Details

510(k) Number	K012270 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 19, 2001
Decision Date	September 28, 2001
Days to Decision	71 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF