Clearance Summary
STEALTH FUSION SYSTEM, MODEL RR 1000 received FDA 510(k) clearance under submission number K043174, sponsored by R&R Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2005-02-07.
- Submission: K043174
- Applicant / Sponsor: R&R Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2005-02-07
Classification & Regulation
This clearance is catalogued under FDA product code KTT and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.