Clearance Summary
RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP W/PANACRYL SUTURE received FDA 510(k) clearance under submission number K060553, sponsored by Depuy Mitek, A Johnson & Johnson Company. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2006-05-04.
- Submission: K060553
- Applicant / Sponsor: Depuy Mitek, A Johnson & Johnson Company
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2006-05-04
Classification & Regulation
This clearance is catalogued under FDA product code JDR and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.