Dynamo Spinal Cement; Salvo® Spine System— 510(k) K260286
Substantially EquivalentSpine Wave, Inc.
FDA 510(k) clearance K260286 for Dynamo Spinal Cement; Salvo® Spine System, Substantially Equivalent on 2026-06-15. Applicant: Spine Wave, Inc.. Device class: 2.
Summary
Spine Wave's clearance names Dynamo Spinal Cement and the Salvo Spine System. The record lists one product code, PML, bone cement for posterior screw augmentation, and doesn't describe how the two relate.
Class II, 21 CFR 888.3027. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Spine Wave filed from Shelton, Connecticut. Review took 137 calendar days (January 29 to June 15, 2026).
Clearance details
- Applicant
- Spine Wave, Inc.
- Product code
- Product code PML
- Device class
- Class 2
- Regulation
- 21 CFR 888.3027
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shelton, CT, US
Recent devices under product code PML
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- K222789 — VADER® Pedicle System, G21 Cement
More clearances from Spine Wave, Inc.
view allAdverse events under product code PML
product code PML- Death
- 8
- Total
- 8
Source: openFDA MAUDE database, through . 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.