Clearance Summary
REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1 received FDA 510(k) clearance under submission number K082419, sponsored by Intra-Lock International, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2009-05-27.
- Submission: K082419
- Applicant / Sponsor: Intra-Lock International, Inc.
- Clearance pathway: Abbreviated
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3045
- Decision date: 2009-05-27
Classification & Regulation
This clearance is catalogued under FDA product code MQV and 21 CFR 888.3045, within the Orthopedic review panel as a Class II device.