Clearance Summary
Daytona® Small Stature Growth Rod Conversion Set received FDA 510(k) clearance under submission number K193224, sponsored by SeaSpine Orthopedics 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 2020-02-13.
- Submission: K193224
- Applicant / Sponsor: SeaSpine Orthopedics Corporation
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2020-02-13
Classification & Regulation
This clearance is catalogued under FDA product code PGM and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.