Clearance Summary
ChM 4.5mm Cortical screws received FDA 510(k) clearance under submission number K210490, sponsored by Chm Sp. Z O.O.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2021-10-05.
- Submission: K210490
- Applicant / Sponsor: Chm Sp. Z O.O.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2021-10-05
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.