Clearance Summary
OSS/(SCARF)- AND OSW-SCREW received FDA 510(k) clearance under submission number K042079, sponsored by O.M.T. Oberflachen-Und Materialtechnologie GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2004-12-20.
- Submission: K042079
- Applicant / Sponsor: O.M.T. Oberflachen-Und Materialtechnologie GmbH
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2004-12-20
Classification & Regulation
This clearance is catalogued under FDA product code HWC and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.