K232484
- 510(k) number
- K232484
- Device name
- KeyLift Expandable Interlaminar Stabilization System
- Applicant
- Amplio Spine, LLC FL · US
- Product code
- PEK — Spinous Process Plate
- Decision date
- 2023-10-19
- Date received
- 2023-08-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K232484.pdf
Official FDA record: K232484
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.