Clearance Summary
VersaTap Suture Anchor (ADP050); VersaPEEK Suture Anchor (APP002); MicroTi Suture Anchor (ATP003-M); VersaLat Ti Suture Anchor (ADP021-TI); VersaLat Suture Anchor (ADP021-PK) received FDA 510(k) clearance under submission number K242296, sponsored by Ortho-Design (Pty), Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2024-08-29.
- Submission: K242296
- Applicant / Sponsor: Ortho-Design (Pty), Ltd.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2024-08-29
Classification & Regulation
This clearance is catalogued under FDA product code MBI and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.