Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Salvo® Robotic Navigation Instruments

K-Number: K243514 · 2025-04-03

ApplicantSpine Wave, Inc.
Decision Date2025-04-03
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Salvo® Robotic Navigation Instruments is a medical device manufactured by Spine Wave, Inc.. It received FDA 510(k) clearance on 2025-04-03 under approval number K243514. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Salvo® Robotic Navigation Instruments?

Salvo® Robotic Navigation Instruments is a medical device that received FDA 510(k) clearance on 2025-04-03. It is manufactured by Spine Wave, Inc.. The 510(k) number is K243514.

When was Salvo® Robotic Navigation Instruments approved by the FDA?

Salvo® Robotic Navigation Instruments received FDA 510(k) clearance on 2025-04-03, under approval number K243514.

What company makes Salvo® Robotic Navigation Instruments?

Salvo® Robotic Navigation Instruments is manufactured by Spine Wave, Inc..

What is the FDA product code for Salvo® Robotic Navigation Instruments?

The FDA product code for Salvo® Robotic Navigation Instruments is OLO.

Related Clinical Trials

NCT07574762 Total Knee Arthroplasty With Personalized Implantation: Computer Navigation-Assisted Surgery Versus Robotic-Assisted Surgery RECRUITING NCT07518615 Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon RECRUITING NCT07516145 Robotic Transjugular Transcatheter Tricuspid Valve Replacement RECRUITING NCT06308120 A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB ACTIVE_NOT_RECRUITING NCT05980442 Comparative Study of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty RECRUITING NCT06962436 RAB Versus Ultrathin Bronchoscopy With VBN in the Diagnosis of PPNs RECRUITING

Other Devices by Spine Wave, Inc.

K161993Leva® Anterior Interbody System K153222Leva Spacer System K160003Sniper (R) Spine System K152620Spine Wave Gen II Expandable Interbody System K172594Proficient® Posterior Cervical Spine System K173175Paramount Anterior Cervical Cage System

View all 22 devices →

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑