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510(k) K260286

Dynamo™ Spinal Cement; Salvo® Spine System by Spine Wave, Inc. — Product Code PML

K260286 is an FDA 510(k) premarket notification submitted by Spine Wave, Inc. for the device "Dynamo™ Spinal Cement; Salvo® Spine System". The FDA issued a decision of Substantially Equivalent on June 15, 2026. The device falls under product code PML (Bone Cement, Posterior Screw Augmentation), a Class II device regulated under 21 CFR 888.3027. Spine Wave, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2026
Date Received
January 29, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Cement, Posterior Screw Augmentation
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

The device is intended to augment the fixation of screws in a posterior spinal system construct.

Other clearances by Spine Wave, Inc.

  • K261159 — Exceed® Biplanar Expandable Interbody System (May 29, 2026)
  • K243816 — Testa TP Pivoting Spacer System (June 27, 2025)
  • K251131 — Annex® 2 Adjacent Level System (June 6, 2025)
  • K243514 — Salvo® Robotic Navigation Instruments (April 3, 2025)
  • K240685 — Salvo® Spine System (May 6, 2024)
  • K231275 — Exceed™ Biplanar Expandable Interbody System (July 25, 2023)
  • K222362 — Salvo® Spine System (August 29, 2022)
  • K202476 — Salvo® Spine System (November 5, 2020)
  • K192526 — Spine Wave Navigated Instruments (October 10, 2019)
  • K191045 — Salvo™ Spine System (July 10, 2019)

Other clearances for product code PML

  • K252885 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (January 22, 2026)
  • K241034 — Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System (June 12, 2024)
  • K231809 — Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Moment (October 20, 2023)
  • K230774 — PERLA® TL System; TEKTONA® HV US Bone Cement (June 23, 2023)
  • K222789 — VADER® Pedicle System, G21 Cement (January 9, 2023)
  • K221926 — Invictus® Bone Cement, Invictus Spinal Fixation System (December 20, 2022)
  • K222256 — BonOs® Inject Bone Cement; NEO Pedicle Screw System™ (August 26, 2022)
  • K212489 — BonOs Inject Bone Cement; NEO Pedicle Screw System (October 28, 2021)
  • K200596 — G21 Cement, VADER® Pedicle System (October 13, 2020)
  • K201362 — CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone (August 19, 2020)

FDA data resources