Clearance Summary
BAUMER PLATES received FDA 510(k) clearance under submission number K930966, sponsored by Baumer Ortopedia , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1994-04-25.
- Submission: K930966
- Applicant / Sponsor: Baumer Ortopedia , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 1994-04-25
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.