Clearance Summary
Cut Screw - Percutaneous Compression Screw received FDA 510(k) clearance under submission number K230397, 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 2023-06-12.
- Submission: K230397
- 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: 2023-06-12
Classification & Regulation
This clearance is catalogued under FDA product code HWC and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.