Clearance Summary
BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS received FDA 510(k) clearance under submission number K060121, sponsored by Biomet Manufacturing Corp. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2006-03-21.
- Submission: K060121
- Applicant / Sponsor: Biomet Manufacturing Corp
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2006-03-21
Classification & Regulation
This clearance is catalogued under FDA product code HAW and 21 CFR 882.4560, within the Neurology review panel as a Class II device.