Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning
FDA 510(k) clearance K212245 · decided 2022-04-13
Clearance details
- K-number
- K212245
- Device name
- Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning
- Applicant
- Brainlab AG
- Decision
- Substantially Equivalent
- Date received
- 2021-07-19
- Decision date
- 2022-04-13
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- OLO
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Munich, DE
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| TMINI Miniature Robotic System (K261024) | THINK Surgical, Inc. | 2026-07-24 |
| Ion-L Navigated Instruments (K262121) | SurGenTec, LLC | 2026-07-24 |
| Op.n™ Spine Navigation and Robotic Guidance (K261113) | Ecential Robotics | 2026-07-22 |
| OTS Hip (K261852) | Ortoma AB | 2026-07-01 |
| VERTICALE® Navigation Instruments (K253921) | Silony Medical GmbH | 2026-06-26 |
| VELYS™ Robotic-Assisted Solution (K260480) | Depuy Ireland UC | 2026-06-25 |
| Dynamis Robotic Surgical System (K260369) | LEM Surgical AG | 2026-06-20 |
| CORUS™ Navigation System-GN (K261665) | Providence Medical Technology, Inc. | 2026-06-18 |
| SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments (K260571) | Life Spine, Inc. | 2026-06-02 |
| Navigated LLIF Impactable Tracker (K261060) | Tyber Medical, LLC | 2026-05-29 |
Recalls involving this device
No recalls on record reference this clearance.