NeckTune 3D SA Cervical Cage— 510(k) K260036
Substantially EquivalentMedyssey Co, Ltd.
FDA 510(k) clearance K260036 for NeckTune 3D SA Cervical Cage, Substantially Equivalent on 2026-06-15. Applicant: Medyssey Co, Ltd.. Device class: 2.
Summary
Medyssey's NeckTune 3D SA Cervical Cage is filed under OVE, cervical intervertebral fusion devices with integrated fixation. The record doesn't expand "3D SA" or list cage sizes.
Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel. The submission was a Traditional 510(k).
Medyssey filed from Jecheon-Si, South Korea. Review took 160 calendar days (January 6 to June 15, 2026).
Clearance details
- Applicant
- Medyssey Co, Ltd.
- Product code
- Product code OVE
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jecheon-Si, KR
Recent devices under product code OVE
view allMore clearances from Medyssey Co, Ltd.
view allAdverse events under product code OVE
product code OVE- Injury
- 293
- Malfunction
- 710
- Total
- 1,003
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.