Clearance Summary
ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106 received FDA 510(k) clearance under submission number K080547, sponsored by Aesculap Implant System, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2008-05-23.
- Submission: K080547
- Applicant / Sponsor: Aesculap Implant System, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2008-05-23
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.