Clearance Summary
Stryker CMF MEDPOR Priority Customized Implant Kit received FDA 510(k) clearance under submission number K191916, sponsored by Stryker Leibinger GmbH & Co KG. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2019-08-15.
- Submission: K191916
- Applicant / Sponsor: Stryker Leibinger GmbH & Co KG
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3550
- Decision date: 2019-08-15
Classification & Regulation
This clearance is catalogued under FDA product code FWP and 21 CFR 878.3550, within the General, Plastic Surgery review panel as a Class II device.