Spinemask Tracker, Spinemap 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, Spinemap 3D 3.0-ENABLE, Spinemap 3D 3.0-SALES D
FDA 510(k) K141941 · Stryker Corporate
510(k) numberK141941
Submission
- Device name
- Spinemask Tracker, Spinemap 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, Spinemap 3D 3.0-ENABLE, Spinemap 3D 3.0-SALES D
- Applicant
- Stryker Corporate
Freiburg, Baden-Wuerttemberg, DE - Received
- July 17, 2014
- Decision date
- October 31, 2014
- 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 |
|---|---|---|
| K153240 | Styrker OrthoMap Express Knee SystemOLO · Traditional | 07/07/2016SE |
| K143597 | Navigated XIA 4.5 Polyaxial ScrewdriverOLO · Traditional | 09/04/2015SE |
| K141551 | Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees)…PGW · Traditional | 09/08/2014SE |
| K131214 | Cranial Map NeuroHAW · Traditional | 10/18/2013SE |
| K130874 | Stryker NAV3I PlatformHAW · Traditional | 09/27/2013SE |
Questions and answers
When was Spinemask Tracker, Spinemap 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, Spinemap 3D 3.0-ENABLE, Spinemap 3D 3.0-SALES D cleared by the FDA?
Spinemask Tracker, Spinemap 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, Spinemap 3D 3.0-ENABLE, Spinemap 3D 3.0-SALES D (K141941) received a 510(k) decision of Substantially Equivalent on October 31, 2014, 106 days after the submission was received.
What is the product code of K141941?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.