FDA 510(k) Applications Submitted by IMPLEX CORP.

FDA 510(k) Number Submission Date Device Name Applicant
K962468 06/25/1996 HEDROCEL ACETABULAR RESTRICTOR IMPLEX CORP.
K971705 05/08/1997 IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED IMPLEX CORP.
K971789 05/14/1997 IMPLEX CONTINUUM POROUS PATELLAR IMPLEX CORP.
K964509 11/08/1996 IMPLEX A-240 HEP ACETABULAR CUP SYSTEM IMPLEX CORP.
K970447 02/06/1997 IMPLEX BIPOLAR HIP SYSTEM IMPLEX CORP.
K955117 11/09/1995 IMPLEX CERAMIC HEAD IMPLEX CORP.
K964882 12/05/1996 IMPLEX REPLACEMENT ACETABULAR CUP INSERT IMPLEX CORP.
K010378 02/08/2001 HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ IMPLEX CORP.
K001039 03/31/2000 THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP IMPLEX CORP.
K001307 04/24/2000 CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YYY-ZZZZZ IMPLEX CORP.
K001759 06/09/2000 HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ IMPLEX CORP.
K983128 09/08/1998 IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY IMPLEX CORP.
K003181 10/11/2000 IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ IMPLEX CORP.
K984290 12/01/1998 IMPLEX RADIAL HEAD REPLACEMENT SYSTEM IMPLEX CORP.
K984291 12/01/1998 CONTINUUM KNEE SYSTEM COBALT CHROMIUM ALLOY TIBIAL COMPONENT IMPLEX CORP.
K994076 12/02/1999 IMPLEX HEDROCEL PS TIBIAL COMPONENT, MODEL HEDROCEL POSTERIOR STABILIZED TIBIAL COMPONENT 05-XXX-YYYYY IMPLEX CORP.
K004013 12/27/2000 IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY IMPLEX CORP.
K992409 07/20/1999 THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ IMPLEX CORP.
K981560 05/01/1998 IMPLEX CONTINUUM KNEE SYSTEM: POROUS TIBIAL COMPONENT MODEL NUMBER 05-230 SYSTEM IMPLEX CORP.
K001471 05/11/2000 THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ IMPLEX CORP.
K982302 07/01/1998 IMPLEX CONTINUUM KNEE - HEDROCEL TIBIAL SPACERS IMPLEX CORP.
K020295 01/28/2002 NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA; ZIMMER CAT # 00-5886-XXYY, IMPLEX PART # 05-121-XXYY-0 IMPLEX CORP.
K040487 02/25/2004 TRABECULAR METAL KNEE SYSTEM AUGMENTS IMPLEX CORP.
K040630 03/10/2004 TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ IMPLEX CORP.
K040756 03/24/2004 THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX IMPLEX CORP.
K031462 05/08/2003 THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS IMPLEX CORP.
K051196 05/10/2005 TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1 IMPLEX CORP.
K031823 06/13/2003 HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 IMPLEX CORP.
K031962 06/25/2003 NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS IMPLEX CORP.
K051978 07/21/2005 TRABECULAR METAL VERTEBRAL BODY REPLACEMENT IMPLEX CORP.
K032282 07/24/2003 MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM IMPLEX CORP.
K032344 07/30/2003 THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 IMPLEX CORP.
K022563 08/02/2002 HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 IMPLEX CORP.
K032527 08/15/2003 HEDROCEL VERTEBRAL BODY REPLACEMENT IMPLEX CORP.
K022966 09/06/2002 PROXILOCK HIP PROSTHESIS; SIZE 12/36 IMPLEX CORP.
K033384 10/23/2003 THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ IMPLEX CORP.
K024161 12/17/2002 NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS IMPLEX CORP.
K990183 01/20/1999 IMPLEX ALUMINA FEMORAL HEAD IMPLEX CORP.
K990330 02/02/1999 CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ IMPLEX CORP.
K980486 02/09/1998 IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM IMPLEX CORP.
K021025 03/29/2002 MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ IMPLEX CORP.
K991869 06/01/1999 COBREX HIP STEM, MODEL 01-128-XXXXX IMPLEX CORP.
K982751 08/06/1998 IMPLEX SCREW AND WASHER SYSTEM IMPLEX CORP.
K983837 10/30/1998 HEDROCEL ACETABULAR CAGE SYSTEM IMPLEX CORP.
K983835 10/30/1998 IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA IMPLEX CORP.
K023882 11/21/2002 THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM IMPLEX CORP.
K980637 02/19/1998 IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT IMPLEX CORP.
K980781 03/02/1998 IMPLEX CONTINUUM KNEE- HEDROCEL REVISION FEMORAL SPACERS IMPLEX CORP.
K031449 05/07/2003 MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION IMPLEX CORP.
K021970 06/17/2002 THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND 02-293-28XX1 (IMPLEX PART #) IMPLEX CORP.
K021967 06/17/2002 HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2 IMPLEX CORP.
K011904 06/19/2001 NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO) IMPLEX CORP.
K012095 07/05/2001 THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND 05-119-XXYY1-0 (IMPLEX) IMPLEX CORP.
K022377 07/22/2002 THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306 IMPLEX CORP.
K012507 08/06/2001 THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY (ZIMMER), 02-212-05XX1 ( IMPLEX) IMPLEX CORP.
K012866 08/27/2001 THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0 IMPLEX CORP.


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