Depuy Mitek

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidFebruary 26, 2026
K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorFebruary 5, 2025
K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsSeptember 11, 2024
K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewMarch 15, 2024
K233675FMS VUE™ Fluid Management and Tissue Debridement SystemFebruary 26, 2024
K143475VAPR Tripolar Suction ElectrodeApril 3, 2015
K120449HEALIX ADVANCE PEEK ANCHORMay 11, 2012
K080918DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STApril 23, 2008
K060664FASTIN RC ANCHORJune 6, 2006
K043298BLUE ORTHOCORD SUTUREDecember 10, 2004
K041117PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS May 28, 2004
K041116SUPER QUICKANCHOR PLUSMay 28, 2004
K041064BIOKNOTLESS RC ANCHORMay 13, 2004
K041065PANALOK RC LOOP ANCHORMay 7, 2004
K040004ORTHOCORD SUTUREApril 13, 2004