Clearance Summary
MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0 received FDA 510(k) clearance under submission number K081867, sponsored by Mako Surgical 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 2008-11-25.
- Submission: K081867
- Applicant / Sponsor: Mako Surgical Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2008-11-25
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.