Cleared Traditional

K952640 - CANNULATED PLUS HIP SCREW (FDA 510(k) Clearance)

K952640 · Wrightmedicaltechnologyinc · Orthopedic device

Jul 1995

Decision

52d

Days

Class 2

Risk

K952640 is an FDA 510(k) clearance for the CANNULATED PLUS HIP SCREW. This device is classified as a Pin, Fixation, Threaded (Class II - Special Controls, product code JDW).

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on July 31, 1995, 52 days after receiving the submission on June 9, 1995.

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

Submission Details

510(k) Number	K952640 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 09, 1995
Decision Date	July 31, 1995
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF