Clearance Summary
BONE SOURCE HAC RAPID SETTING CEMENT received FDA 510(k) clearance under submission number K043334, 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 2005-02-09.
- Submission: K043334
- Applicant / Sponsor: Stryker Instruments
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5300
- Decision date: 2005-02-09
Classification & Regulation
This clearance is catalogued under FDA product code GXP and 21 CFR 882.5300, within the Neurology review panel as a Class II device.