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FDA 510(k)

Dynamo™ Spinal Cement; Salvo® Spine System

K-Number: K260286 · 2026-06-15

ApplicantSpine Wave, Inc.
Decision Date2026-06-15
Product CodePML
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Dynamo™ Spinal Cement; Salvo® Spine System is the device name listed in this FDA 510(k) record. The listed applicant is Spine Wave, Inc.. It received FDA 510(k) clearance on 2026-06-15 under 510(k) number K260286. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dynamo™ Spinal Cement; Salvo® Spine System?

Dynamo™ Spinal Cement; Salvo® Spine System is a medical device that received FDA 510(k) clearance on 2026-06-15. The listed applicant is Spine Wave, Inc.. The 510(k) number is K260286.

When did Dynamo™ Spinal Cement; Salvo® Spine System receive FDA 510(k) clearance?

Dynamo™ Spinal Cement; Salvo® Spine System received FDA 510(k) clearance on 2026-06-15, under 510(k) number K260286.

Who is the listed applicant for Dynamo™ Spinal Cement; Salvo® Spine System?

The FDA 510(k) record lists Spine Wave, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dynamo™ Spinal Cement; Salvo® Spine System?

The FDA product code for Dynamo™ Spinal Cement; Salvo® Spine System is PML.

Other records listing Spine Wave, Inc. as applicant

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Related Devices (Code: PML)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura MedicalK241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone CementUlrich Medical USAK230774PERLA® TL System; TEKTONA® HV US Bone CementSpineartK222789VADER® Pedicle System, G21 CementIcotec AGK221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.

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.

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