Clearance Summary
EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System received FDA 510(k) clearance under submission number K171439, sponsored by Medos International SARL. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2017-07-20.
- Submission: K171439
- Applicant / Sponsor: Medos International SARL
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 2017-07-20
Classification & Regulation
This clearance is catalogued under FDA product code KWQ and 21 CFR 888.3060, within the Orthopedic review panel as a Class II device.