K232619
- 510(k) number
- K232619
- Device name
- MATRIX HA PEEK Cervical IBF System
- Applicant
- Sapphire Medical Group CA · US
- Product code
- ODP — Intervertebral Fusion Device With Bone Graft, Cervic
- Decision date
- 2024-03-19
- Date received
- 2023-08-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K232619.pdf
Official FDA record: K232619
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.