Clearance Summary
GMReis Suture Anchors received FDA 510(k) clearance under submission number K252664, 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 2025-11-04.
- Submission: K252664
- Applicant / Sponsor: GM Dos Reis Industria e Comercio Ltda.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2025-11-04
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.