Clearance Summary
STRYKER NAVIGATION SYSTEM - CT-BASED HIP MODULE, MODEL 6007-621-000 received FDA 510(k) clearance under submission number K050615, sponsored by Stryker Instruments. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2005-04-21.
- Submission: K050615
- Applicant / Sponsor: Stryker Instruments
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2005-04-21
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.