Clearance Summary
COUGAR SYSTEM received FDA 510(k) clearance under submission number K113348, sponsored by Johnson & Johnson. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2011-12-13.
- Submission: K113348
- Applicant / Sponsor: Johnson & Johnson
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2011-12-13
Classification & Regulation
This clearance is catalogued under FDA product code MAX and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.