Cleared Traditional

ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000

K083009 · Stryker Leibinger GmbH & Co KG · Orthopedic

Feb 2009

Decision

133d

Days

Class 2

Risk

About This 510(k) Submission

K083009 is an FDA 510(k) clearance for the ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Stryker Leibinger GmbH & Co KG (Freiburg Baden-Wurttemberg, DE). The FDA issued a Cleared decision on February 19, 2009, 133 days after receiving the submission on October 9, 2008. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K083009 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 09, 2008
Decision Date	February 19, 2009
Days to Decision	133 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.