Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)
FDA 510(k) clearance K251073 · decided 2025-07-23
Clearance details
- K-number
- K251073
- Device name
- Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)
- Applicant
- Innovasis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-04-08
- Decision date
- 2025-07-23
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- OLO
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Innovasis
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) (K261410) | Suite 201, National Innovation Centre | 2026-07-30 |
| SPINEART Navigation Instrument System (K261205) | Spineart SA | 2026-07-29 |
| 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
| Record | Firm | Date |
|---|---|---|
| Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System recall (Z-2859-2026) | Innovasis, Inc | 2026-08-03 |