Cleared Traditional

K011319 - STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX (FDA 510(k) Clearance)

K011319 · Stryker Endoscopy · Orthopedic device

Jul 2001

Decision

80d

Days

Class 2

Risk

K011319 is an FDA 510(k) clearance for the STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX. 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 July 20, 2001, 80 days after receiving the submission on May 1, 2001.

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

Submission Details

510(k) Number	K011319 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 01, 2001
Decision Date	July 20, 2001
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF