Ortho-Map-Oncology Navigation Software, Models 6005-650-000, 6005-651-000
FDA 510(k) K083009 · Stryker Leibinger GmbH & Co KG
510(k) numberK083009
Submission
- Device name
- Ortho-Map-Oncology Navigation Software, Models 6005-650-000, 6005-651-000
- Applicant
- Stryker Leibinger GmbH & Co KG
Freiburg Baden-Wurttemberg, DE - Received
- October 9, 2008
- Decision date
- February 19, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLO – Orthopedic Stereotaxic Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Specialty
- Neurology
Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
Other 510(k)s with product code OLO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262506 | Remex Spine Surgery Navigation - Universal InstrumentsOLO · Special | Remex Medical Corp. | 08/20/2026SE |
| K261410 | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…OLO · Traditional | Suite 201, National Innovation Centre | 07/30/2026SE |
| K261205 | SPINEART Navigation Instrument SystemOLO · Traditional | Spineart SA | 07/29/2026SE |
| K262121 | Ion-L Navigated InstrumentsOLO · Special | SurGenTec, LLC | 07/24/2026SE |
| K261024 | TMINI Miniature Robotic SystemOLO · Traditional | THINK Surgical, Inc. | 07/24/2026SE |
| K261113 | Op.n Spine Navigation and Robotic GuidanceOLO · Traditional | Ecential Robotics | 07/22/2026SE |
| K261852 | OTS HipOLO · Special | Ortoma AB | 07/01/2026SE |
| K253921 | VERTICALE® Navigation InstrumentsOLO · Traditional | Silony Medical GmbH | 06/26/2026SE |
| K260480 | VELYS Robotic-Assisted SolutionOLO · Traditional | Depuy Ireland UC | 06/25/2026SE |
| K260369 | Dynamis Robotic Surgical SystemOLO · Traditional | LEM Surgical AG | 06/20/2026SE |
More from LEM Surgical AG
| 510(k) | Device | Decision |
|---|---|---|
| K261054 | RibPlate SystemHRS · Traditional | 07/01/2026SE |
| K254233 | MEDPOR Customized Implant KitFWP · Special | 03/12/2026SE |
| K253623 | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…OLO · Traditional | 02/19/2026SE |
| K252871 | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…OLO · Traditional | 02/06/2026SE |
| K243491 | SternalPlate ExpansionHRS · Special | 12/11/2024SE |
| K241517 | Q Guidance System; Mako Spine System;OLO · Traditional | 08/27/2024SE |
| K241171 | Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…OLO · Traditional | 07/25/2024SE |
| K240651 | MRI UniversalJEY · Traditional | 07/12/2024SE |
| K240662 | Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…OLO · Traditional | 06/06/2024SE |
| K233542 | Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho…OLO · Traditional | 03/14/2024SE |
Questions and answers
When was Ortho-Map-Oncology Navigation Software, Models 6005-650-000, 6005-651-000 cleared by the FDA?
Ortho-Map-Oncology Navigation Software, Models 6005-650-000, 6005-651-000 (K083009) received a 510(k) decision of Substantially Equivalent on February 19, 2009, 133 days after the submission was received.
What is the product code of K083009?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.