K260850
- 510(k) number
- K260850
- Device name
- OSTEOMNI SPINAL CAGES SYSTEM
- Applicant
- Osteomni, Inc. FL · US
- Product code
- ODP — Intervertebral Fusion Device With Bone Graft, Cervic
- Decision date
- 2026-05-12
- Date received
- 2026-03-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K260850.pdf
Official FDA record: K260850
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.