K250554
- 510(k) number
- K250554
- Device name
- prodisc® L Instruments
- Applicant
- Centinel Spine, LLC PA · US
- Product code
- QLQ — Manual Instruments Designed For Use With Total Disc
- Decision date
- 2025-04-25
- Date received
- 2025-02-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K250554.pdf
Official FDA record: K250554
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.