Clearance Summary
Stryker Resorbable Fixation System received FDA 510(k) clearance under submission number K231208, sponsored by Stryker Leibinger GmbH & Co KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2023-08-14.
- Submission: K231208
- Applicant / Sponsor: Stryker Leibinger GmbH & Co KG
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5360
- Decision date: 2023-08-14
Classification & Regulation
This clearance is catalogued under FDA product code HBW and 21 CFR 882.5360, within the Neurology review panel as a Class II device.