Clearance Summary
SureMAX Family of Cervical Spacers received FDA 510(k) clearance under submission number K193359, sponsored by Additive Implants, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2020-01-03.
- Submission: K193359
- Applicant / Sponsor: Additive Implants, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2020-01-03
Classification & Regulation
This clearance is catalogued under FDA product code ODP and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.