K234035
- 510(k) number
- K234035
- Device name
- COSINE Spacer
- Applicant
- Globus Medical, Inc. PA · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2024-09-06
- Date received
- 2023-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K234035.pdf
Official FDA record: K234035
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.