Clearance Summary
Sternal Cable System received FDA 510(k) clearance under submission number K180582, sponsored by A & E Medical Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2018-05-31.
- Submission: K180582
- Applicant / Sponsor: A & E Medical Corporation
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3010
- Decision date: 2018-05-31
Classification & Regulation
This clearance is catalogued under FDA product code JDQ and 21 CFR 888.3010, within the Orthopedic review panel as a Class II device.