Spine Wave Navigated Instruments
by Spine Wave, Inc. 2 variants
510(k) K192526
Spine Wave Navigated Instruments is a Class II device made by Spine Wave, Inc., cleared under FDA 510(k) K192526 on 10 Oct 2019, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK192526 | Date10 Oct 2019 | StatusActive |
Official records
- FDA 510(k) database K192526
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLO
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K192526
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Salvo® Spine System 10-8358 | 10-8358 | 10840642161083 | On the market | |
| Salvo® Spine System 10-8477 | 10-8477 | 10840642168587 | On the market | |
| Salvo® Spine System 10-8489 | 10-8489 | 10840642166637 | On the market | |
| Salvo® Spine System 10-8491 | 10-8491 | 10840642164008 | On the market | |
| Salvo® Spine System 10-8493 | 10-8493 | 10840642164022 | On the market | |
| Salvo® Spine System 10-8688 | 10-8688 / 10-8688 | 10840642175585 | On the market |
Similar devices
Other devices filed under FDA product code OLO (Orthopedic Stereotaxic Instrument).
- Remex Spine Surgery Navigation System II by Remex Medical Corp.
- REAL INTELLIGENCE CORI (CORI) by Blue Belt Technologies, Inc.
- CD HORIZON® Spinal System RBT011004 by MEDTRONIC SOFAMOR DANEK, INC.
- OMNIBotics KS-62030 by OMNIlife science, Inc.
- StealthStation S8 Spine Software v1.0.0 by MEDTRONIC NAVIGATION, INC.
- VIZADISC 107120 by MAKO Surgical Corp.
- OMNIBotics 4148-1005 by OMNIlife science, Inc.
- ARVIS ® IN-28120 by KICO KNEE INNOVATION COMPANY PTY LIMITED
- TSolution One Cup1 Surgical System by Think Surgical Inc.
- Medtronic 9735249 by Medtronic Navigation Inc.