K240566
- 510(k) number
- K240566
- Device name
- Reef L Interbody System; WaveForm L Interbody System
- Applicant
- SeaSpine Orthopedics Corporation CA · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2024-04-26
- Date received
- 2024-02-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K240566.pdf
Official FDA record: K240566
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.