Clearance Summary
Stryker MP, Mandible, HMMF and MMF AXS Screws received FDA 510(k) clearance under submission number K231599, sponsored by Stryker Leibinger GmbH & Co KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2023-08-24.
- Submission: K231599
- Applicant / Sponsor: Stryker Leibinger GmbH & Co KG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4880
- Decision date: 2023-08-24
Classification & Regulation
This clearance is catalogued under FDA product code DZL and 21 CFR 872.4880, within the Dental review panel as a Class II device.