FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Salvo® Robotic Navigation Instruments
K Number: K243514
·
Decision Apr 3, 2025
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
59
Review Days
141
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Basic Information
- Device Name
- Salvo® Robotic Navigation Instruments
- K Number
- K243514
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spine Wave, Inc.
- Date Received
- November 13, 2024
- Decision Date
- April 3, 2025
- Product Code
- OLO
- Advisory Committee
- Neurology
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | FDA class 2 | Neurology |
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Other Clearances by Spine Wave, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260286 | Dynamo Spinal Cement; Salvo® Spine System | Jun 15, 2026 | Substantially Equivalent |
| K261159 | Exceed® Biplanar Expandable Interbody System | May 29, 2026 | Substantially Equivalent |
| K243816 | Testa TP Pivoting Spacer System | Jun 27, 2025 | Substantially Equivalent |
| K251131 | Annex® 2 Adjacent Level System | Jun 6, 2025 | Substantially Equivalent |
| K240685 | Salvo® Spine System | May 6, 2024 | Substantially Equivalent |
| K231275 | Exceed Biplanar Expandable Interbody System | Jul 25, 2023 | Substantially Equivalent |
| K222362 | Salvo® Spine System | Aug 29, 2022 | Substantially Equivalent |
| K202476 | Salvo® Spine System | Nov 5, 2020 | Substantially Equivalent |
| K192526 | Spine Wave Navigated Instruments | Oct 10, 2019 | Substantially Equivalent |
| K191045 | Salvo Spine System | Jul 10, 2019 | Substantially Equivalent |