Cleared Traditional

K050535 - STRYKER MMF SCREW (FDA 510(k) Clearance)

K050535 · Stryker Instruments · Dental device

Mar 2005

Decision

15d

Days

Class 2

Risk

K050535 is an FDA 510(k) clearance for the STRYKER MMF SCREW. This device is classified as a Screw, Fixation, Intraosseous (Class II - Special Controls, product code DZL).

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on March 17, 2005, 15 days after receiving the submission on March 2, 2005.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4880.

Submission Details

510(k) Number	K050535 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 02, 2005
Decision Date	March 17, 2005
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF