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.
Clearance details
- Applicant
- Spine Wave, Inc.
- Product code
- 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
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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.