Clearance Summary
REVERTO 55 AND 37 SHAPE MEMORY STAPLES received FDA 510(k) clearance under submission number K071477, sponsored by Core Essence 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 2007-08-15.
- Submission: K071477
- Applicant / Sponsor: Core Essence Orthopaedics, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2007-08-15
Classification & Regulation
This clearance is catalogued under FDA product code JDR and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.