Clearance Summary
PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR received FDA 510(k) clearance under submission number K063273, sponsored by Depuy Miltek, A Johnson & Johnson Co.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2006-11-22.
- Submission: K063273
- Applicant / Sponsor: Depuy Miltek, A Johnson & Johnson Co.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2006-11-22
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.