Clearance Summary
LINK ACETABULAR MESH received FDA 510(k) clearance under submission number K844225, sponsored by Waldemar Link GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1984-11-14.
- Submission: K844225
- Applicant / Sponsor: Waldemar Link GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 1984-11-14
Classification & Regulation
This clearance is catalogued under FDA product code FTM and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.