Clearance Summary
GMReis Ankle Plating System received FDA 510(k) clearance under submission number K242998, sponsored by GM Dos Reis Industria e Comercio Ltda.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2024-11-21.
- Submission: K242998
- Applicant / Sponsor: GM Dos Reis Industria e Comercio Ltda.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2024-11-21
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.