Salvo® Robotic Navigation Instruments— 510(k) K243514

Name: FDA 510(k) clearance K243514
Creator: U.S. Food and Drug Administration
Published: 2025-04-03

Substantially Equivalent

Spine Wave, Inc.

FDA 510(k) clearance K243514 for Salvo® Robotic Navigation Instruments, Substantially Equivalent on 2025-04-03. Applicant: Spine Wave, Inc.. Device class: 2.

Clearance details

Applicant: Spine Wave, Inc.
Product code: Code OLO
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2024-11-13
Decision date: 2025-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shelton, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLO

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K262506 — Remex Spine Surgery Navigation - Universal Instruments2026-08-20
K261410 — Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))2026-07-30
K261205 — SPINEART Navigation Instrument System2026-07-29
K261024 — TMINI Miniature Robotic System2026-07-24
K262121 — Ion-L Navigated Instruments2026-07-24

More clearances from Spine Wave, Inc.

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K260286 — Dynamo Spinal Cement; Salvo® Spine System2026-06-15
K261159 — Exceed® Biplanar Expandable Interbody System2026-05-29
K243816 — Testa TP Pivoting Spacer System2025-06-27
K251131 — Annex® 2 Adjacent Level System2025-06-06
K240685 — Salvo® Spine System2024-05-06

Adverse events under product code OLO

product code OLO

Death: 11
Injury: 2,799
Malfunction: 11,105
Other: 1
Total: 13,916

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.