Clearance Summary
Brainlab Compatible K2M Navigation Instruments received FDA 510(k) clearance under submission number K192911, sponsored by K2m, 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 2019-11-14.
- Submission: K192911
- Applicant / Sponsor: K2m, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2019-11-14
Classification & Regulation
This clearance is catalogued under FDA product code OLO and 21 CFR 882.4560, within the Neurology review panel as a Class II device.