Clearance Summary
Sternal Cable System received FDA 510(k) clearance under submission number K193479, 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 2020-03-23.
- Submission: K193479
- Applicant / Sponsor: A & E Medical Corporation
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3010
- Decision date: 2020-03-23
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.