K253118
- 510(k) number
- K253118
- Device name
- Companion Spine DIAM Instrumentation
- Applicant
- Companion Spine France FR
- Product code
- QLR — Manual Instruments Designed For Use With Non-Fusion
- Decision date
- 2025-12-16
- Date received
- 2025-09-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K253118.pdf
Official FDA record: K253118
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.