Dynamo Spinal Cement; Salvo® Spine System
FDA 510(k) K260286 · Spine Wave, Inc.
510(k) numberK260286
Submission
- Device name
- Dynamo Spinal Cement; Salvo® Spine System
- Applicant
- Spine Wave, Inc.
Shelton, CT, US - Received
- January 29, 2026
- Decision date
- June 15, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PML – Bone Cement, Posterior Screw Augmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3027
- Specialty
- Orthopedic
- Implant
- Yes
The device is intended to augment the fixation of screws in a posterior spinal system construct.
Other 510(k)s with product code PML
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252885 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemPML · Traditional | Astura Medical | 01/22/2026SE |
| K241034 | Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemPML · Traditional | Medacta International S.A. | 06/12/2024SE |
| K231809 | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…PML · Traditional | Ulrich Medical USA | 10/20/2023SE |
| K230774 | PERLA® TL System; TEKTONA® HV US Bone CementPML · Traditional | Spineart | 06/23/2023SE |
| K222789 | VADER® Pedicle System, G21 CementPML · Traditional | Icotec AG | 01/09/2023SE |
| K221926 | Invictus® Bone Cement, Invictus Spinal Fixation SystemPML · Traditional | Alphatec Spine, Inc. | 12/20/2022SE |
| K222256 | BonOs® Inject Bone Cement; NEO Pedicle Screw SystemPML · Special | Neo Medical SA | 08/26/2022SE |
| K212489 | BonOs Inject Bone Cement; NEO Pedicle Screw SystemPML · Traditional | Neo Medical SA | 10/28/2021SE |
| K200596 | G21 Cement, VADER® Pedicle SystemPML · Traditional | Icotec AG | 10/13/2020SE |
| K201362 | CD Horizon Fenestrated Screw Set, CD Horizon Spinal System, Kyphon HV-R Bone CementPML · Traditional | Medtronic | 08/19/2020SE |
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| K243514 | Salvo® Robotic Navigation InstrumentsOLO · Traditional | 04/03/2025SE |
| K240685 | Salvo® Spine SystemNKB · Traditional | 05/06/2024SE |
| K231275 | Exceed Biplanar Expandable Interbody SystemMAX · Traditional | 07/25/2023SE |
| K222362 | Salvo® Spine SystemNKB · Special | 08/29/2022SE |
| K202476 | Salvo® Spine SystemNKB · Traditional | 11/05/2020SE |
| K192526 | Spine Wave Navigated InstrumentsOLO · Special | 10/10/2019SE |
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Questions and answers
When was Dynamo Spinal Cement; Salvo® Spine System cleared by the FDA?
Dynamo Spinal Cement; Salvo® Spine System (K260286) received a 510(k) decision of Substantially Equivalent on June 15, 2026, 137 days after the submission was received.
What is the product code of K260286?
The FDA product code is PML – Bone Cement, Posterior Screw Augmentation, a Class II (moderate risk) device regulated under 21 CFR 888.3027.