K253392
- 510(k) number
- K253392
- Device name
- Synergy Disc Instruments
- Applicant
- Synergy Spine Solutions, Inc. CO · US
- Product code
- QLQ — Manual Instruments Designed For Use With Total Disc
- Decision date
- 2026-03-27
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K253392.pdf
Official FDA record: K253392
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.