Clearance Summary
EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES received FDA 510(k) clearance under submission number K061134, sponsored by Efs Eberle Feinwerktechnische Systeme. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2006-09-01.
- Submission: K061134
- Applicant / Sponsor: Efs Eberle Feinwerktechnische Systeme
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 2006-09-01
Classification & Regulation
This clearance is catalogued under FDA product code HRX and 21 CFR 888.1100, within the Orthopedic review panel as a Class II device.