FDA 510(k) Applications Submitted by Marci Halevi

FDA 510(k) Number Submission Date Device Name Applicant
K190342 02/14/2019 BIAFINE Topical Cream Bausch Health Americas Incorporated
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.
K050766 03/25/2005 EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM ZIMMER TRABECULAR
K050937 04/14/2005 TRABECULAR METAL ACETABULAR REVISION SHELLS ZIMMER TRABECULAR
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.
K071668 06/19/2007 ORTHOBIOM SPINAL SYSTEM PARADIGM SPINE
K031962 06/25/2003 NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS IMPLEX CORP.
K051756 06/29/2005 MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ ZIMMER TRABECULAR
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.
K042871 10/18/2004 TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3 ZIMMER TRABECULAR
K052950 10/20/2005 THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM ZIMMER TRABECULAR
K033384 10/23/2003 THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ IMPLEX CORP.
K043061 11/05/2004 THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX ZIMMER TRABECULAR
K053340 12/01/2005 TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS ZIMMER TRABECULAR
K024161 12/17/2002 NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS IMPLEX CORP.


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