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FDA 510(k) Applications Submitted by ENDOTEC, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K012702
08/14/2001
BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1
ENDOTEC, INC.
K982418
07/13/1998
BUECHEL-PAPPAS MODULAR SALVAGE STEM
ENDOTEC, INC.
K960424
01/29/1996
BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD
ENDOTEC, INC.
K960425
01/29/1996
BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX
ENDOTEC, INC.
K992394
07/19/1999
BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT
ENDOTEC, INC.
K081400
05/19/2008
FANNING-PAPPAS MODULAR KNEE BEARING
ENDOTEC, INC.
K963100
08/09/1996
TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP
ENDOTEC, INC.
K963101
08/09/1996
B-P HEMISPHERICAL ACETABULAR COMPONENT
ENDOTEC, INC.
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