Medical Device Manufacturer · US , South Orange , NJ

Endotec, Inc. - FDA 510(k) Cleared Devices

15 submissions · 14 cleared · Since 1991
15
Total
14
Cleared
0
Denied

Endotec, Inc. has 14 FDA 510(k) cleared orthopedic devices. Based in South Orange, US.

Historical record: 14 cleared submissions from 1991 to 2009.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Endotec, Inc.
15 devices
1-15 of 15
Cleared Feb 20, 2009
FANNING-PAPPAS MODULAR KNEE BEARING
K081400 · JWH
Orthopedic · 277d
Cleared Jan 30, 2002
BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1
K012702 · JWH
Orthopedic · 169d
Cleared Oct 15, 1999
BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT
K992394 · HSD
Orthopedic · 88d
Cleared Apr 29, 1999
BUECHEL-PAPPAS MODULAR SALVAGE STEM
K982418 · MJT
Orthopedic · 290d
Cleared Feb 12, 1997
TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD...
K963100 · LPH
Orthopedic · 187d
Cleared Feb 12, 1997
B-P HEMISPHERICAL ACETABULAR COMPONENT
K963101 · LPH
Orthopedic · 187d
Cleared Oct 03, 1996
BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX
K960425 · JDI
Orthopedic · 248d
Cleared Aug 26, 1996
BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD
K960424 · KWT
Orthopedic · 210d
Cleared Jun 06, 1995
ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES
K945254 · GEI
General & Plastic Surgery · 221d
Cleared Sep 28, 1994
CARRIER, LIGATURE (79 GEJ)
K944465 · GCJ
General & Plastic Surgery · 16d
Cleared Sep 27, 1994
DEKALB
K944414 · GCJ
General & Plastic Surgery · 19d
Cleared May 19, 1993
BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH
K905262 · JDI
Orthopedic · 908d
Cleared May 23, 1991
MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON
K904870 · KXA
Orthopedic · 212d
Cleared Jan 28, 1991
BEUCHEL-PAPPAS GLENOID COMPONENT
K904879 · KWS
Orthopedic · 90d
Cleared Jan 28, 1991
BUECHEL-PAPPAS HUMERAL STEM COMPONENT
K904880 · KWS
Orthopedic · 90d
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