Cleared Traditional

ORTHOMAP 3D 1.1 MODULE

K093206 · Stryker Corp. · Orthopedic

Aug 2010

Decision

295d

Days

Class 2

Risk

About This 510(k) Submission

K093206 is an FDA 510(k) clearance for the ORTHOMAP 3D 1.1 MODULE, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Stryker Corp. (Freiburg, DE). The FDA issued a Cleared decision on August 4, 2010, 295 days after receiving the submission on October 13, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K093206 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 13, 2009
Decision Date	August 04, 2010
Days to Decision	295 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OLO — Orthopedic Stereotaxic Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.