Clearance Summary
R&R EXTERNAL FIXATION SYSTEM received FDA 510(k) clearance under submission number K052005, 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 2005-09-06.
- Submission: K052005
- Applicant / Sponsor: R&R Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2005-09-06
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.