K234077
- 510(k) number
- K234077
- Device name
- SPIRA® Anterior Lumbar Spacers
- Applicant
- Camber Spine Technologies PA · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2024-07-12
- Date received
- 2023-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 3.5 MB · U.S. public domain
Also available from FDA: K234077.pdf
Official FDA record: K234077
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.