TeDan Surgical Innovations LLC

FDA Regulatory Profile

Summary

Total Recalls
13
510(k) Clearances
3
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2525-2020Class II3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction iMay 15, 2020
Z-2528-2020Class IIPHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be usedMay 15, 2020
Z-2529-2020Class IIPHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be usedMay 15, 2020
Z-2526-2020Class IIPHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraMay 15, 2020
Z-2530-2020Class IIPHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended to be useMay 15, 2020
Z-2527-2020Class IIPHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraMay 15, 2020
Z-2524-2020Class II3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction iMay 15, 2020
Z-1845-2020Class IIFukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product UJuly 16, 2019
Z-1506-2020Class IIDS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intendeFebruary 18, 2019
Z-1505-2020Class IIDS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intendeFebruary 18, 2019
Z-1504-2020Class IID-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws andFebruary 18, 2019
Z-1503-2020Class IID-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws andFebruary 18, 2019
Z-2385-2012Class IISterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB SurgiJune 11, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K231691Phantom XL Insulated DilatorsJune 29, 2023
K161318Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding SystemsMarch 20, 2017
K140088PHANTOM XL INSULATED DILATORSSeptember 25, 2014