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Implex Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
65
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K051978TRABECULAR METAL VERTEBRAL BODY REPLACEMENTSeptember 23, 2005
K051196TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1June 17, 2005
K040487TRABECULAR METAL KNEE SYSTEM AUGMENTSDecember 21, 2004
K040630TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZSeptember 30, 2004
K040756THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXXJuly 14, 2004
K031962NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTSJanuary 8, 2004
K033384THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZNovember 19, 2003
K032527HEDROCEL VERTEBRAL BODY REPLACEMENTOctober 31, 2003
K032344THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330October 2, 2003
K031449MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTIONSeptember 23, 2003
K032282MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEMAugust 21, 2003
K031462THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTSAugust 6, 2003
K031823HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1July 11, 2003
K023882THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEMFebruary 19, 2003
K024161NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTSJanuary 15, 2003
K022377THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306December 10, 2002
K022966PROXILOCK HIP PROSTHESIS; SIZE 12/36October 2, 2002
K022563HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1August 30, 2002
K021967HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2July 17, 2002
K021970THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND 02-293-28XX1 (IMPLEX PJuly 12, 2002