Medical Device Manufacturer · US , South Orange , NJ

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

15 submissions · 14 cleared · Since 1991

Total

Cleared

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

1-12 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

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

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