Medical Device Manufacturer · US , Allendale , NJ

Implex Corp. - FDA 510(k) Cleared Devices

65 submissions · 61 cleared · Since 1993
65
Total
61
Cleared
0
Denied
65 devices
26-50 of 65
Cleared Jul 26, 2001
THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND...
K012095 · JWH
Orthopedic · 21d
Cleared Jul 19, 2001
NEXGEN PRIMARY POROUS PATELLA, MODEL...
K011904 · JWH
Orthopedic · 30d
Cleared Jan 25, 2001
IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY
K004013 · JWH
Orthopedic · 29d
Cleared Nov 07, 2000
IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ
K003181 · LPH
Orthopedic · 27d
Cleared Aug 24, 2000
HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ
K001759 · JDI
Orthopedic · 76d
Cleared Aug 07, 2000
THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ
K001471 · LWJ
Orthopedic · 88d
Cleared Jun 15, 2000
THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP
K001039 · LPH
Orthopedic · 76d
Cleared May 23, 2000
CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YYY-ZZZZZ
K001307 · JWH
Orthopedic · 29d
Cleared Mar 01, 2000
CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ
K990330 · JDI
Orthopedic · 393d
Cleared Feb 18, 2000
IMPLEX HEDROCEL PS TIBIAL COMPONENT, MODEL HEDROCEL POSTERIOR STABILIZED...
K994076 · JWH
Orthopedic · 78d
Cleared Oct 08, 1999
THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ
K992409 · JDI
Orthopedic · 80d
Cleared Jul 14, 1999
COBREX HIP STEM, MODEL 01-128-XXXXX
K991869 · JDI
Orthopedic · 43d
Cleared Jul 01, 1999
HEDROCEL ACETABULAR CAGE SYSTEM
K983837 · LPH
Orthopedic · 244d
Cleared Jun 11, 1999
IMPLEX ALUMINA FEMORAL HEAD
K990183 · LZO
Orthopedic · 142d
Cleared Jun 01, 1999
IMPLEX RADIAL HEAD REPLACEMENT SYSTEM
K984290 · KWI
Orthopedic · 182d
Cleared Mar 15, 1999
IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA
K983835 · JWH
Orthopedic · 136d
Cleared Feb 01, 1999
IMPLEX SCREW AND WASHER SYSTEM
K982751 · MBI
Orthopedic · 179d
Cleared Feb 01, 1999
CONTINUUM KNEE SYSTEM COBALT CHROMIUM ALLOY TIBIAL COMPONENT
K984291 · JWH
Orthopedic · 62d
Cleared Dec 16, 1998
IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT
K980637 · JWH
Orthopedic · 300d
Cleared Dec 03, 1998
IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY,...
K983128 · JDI
Orthopedic · 86d
Cleared Jul 31, 1998
IMPLEX CONTINUUM KNEE - HEDROCEL TIBIAL SPACERS
K982302 · JWH
Orthopedic · 30d
Cleared Jun 08, 1998
IMPLEX CONTINUUM KNEE SYSTEM: POROUS TIBIAL COMPONENT MODEL NUMBER 05-230 SYSTEM
K981560 · JWH
Orthopedic · 38d
Cleared May 22, 1998
IMPLEX CONTINUUM KNEE- HEDROCEL REVISION FEMORAL SPACERS
K980781 · JWH
Orthopedic · 81d
Cleared Apr 14, 1998
IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM
K980486 · JDI
Orthopedic · 64d
Cleared Aug 06, 1997
IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED
K971705 · JDI
Orthopedic · 90d
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