510(k) clearance
NeckTune™ SA Cervical Cage
- 510(k) number
- K262726
- Applicant
- Medyssey Co., Ltd.
- Decision date
- Sep 29, 2026
- Date received
- Jul 31, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- OVE
- Device type
- Intervertebral Fusion Device With Integrated Fixation, Cervical
- Device class
- Class II
- Regulation
- 21 CFR 888.3080
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Jecheon-Si, KR