K260036
- 510(k) number
- K260036
- Device name
- NeckTune 3D SA Cervical Cage
- Applicant
- Medyssey Co, Ltd. KR
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2026-06-15
- Date received
- 2026-01-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K260036.pdf
Official FDA record: K260036
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.