Clearance Summary
Additive Orthopaedics Bunion System received FDA 510(k) clearance under submission number K163593, sponsored by Additive Orthopaedics, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2017-06-20.
- Submission: K163593
- Applicant / Sponsor: Additive Orthopaedics, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2017-06-20
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.