The following data is part of a premarket notification filed by Stryker Leibinger Gmbh & Co. Kg with the FDA for Ortho-map-oncology Navigation Software, Models 6005-650-000, 6005-651-000.
| Device ID | K083009 |
| 510k Number | K083009 |
| Device Name: | ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000 |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Stryker Leibinger GmbH & Co. KG BOTZINGER STRASSE 41 Freiburg, DE D-79111 |
| Contact | Lilian Eckert |
| Correspondent | Lilian Eckert Stryker Leibinger GmbH & Co. KG BOTZINGER STRASSE 41 Freiburg, DE D-79111 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-09 |
| Decision Date | 2009-02-19 |
| Summary: | summary |