Endotec, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
5
Compliance Actions
2

Recent 510(k) Clearances

K-NumberDeviceDate
K081400FANNING-PAPPAS MODULAR KNEE BEARINGFebruary 20, 2009
K012702BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1January 30, 2002
K992394BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENTOctober 15, 1999
K982418BUECHEL-PAPPAS MODULAR SALVAGE STEMApril 29, 1999
K963100TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUPFebruary 12, 1997
K963101B-P HEMISPHERICAL ACETABULAR COMPONENTFebruary 12, 1997
K960425BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXXOctober 3, 1996
K960424BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=ODAugust 26, 1996
K945254ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIESJune 6, 1995
K944465CARRIER, LIGATURE (79 GEJ)September 28, 1994
K944414DEKALBSeptember 27, 1994
K905262BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTHMay 19, 1993
K904870MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPONMay 23, 1991
K904880BUECHEL-PAPPAS HUMERAL STEM COMPONENTJanuary 28, 1991
K904879BEUCHEL-PAPPAS GLENOID COMPONENTJanuary 28, 1991