K260286
- 510(k) number
- K260286
- Device name
- Dynamo Spinal Cement; Salvo® Spine System
- Applicant
- Spine Wave, Inc. CT · US
- Product code
- PML — Bone Cement, Posterior Screw Augmentation
- Decision date
- 2026-06-15
- Date received
- 2026-01-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K260286.pdf
Official FDA record: K260286
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.