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
FDA 510(k) Regulatory Record - Implex Corp. General & Plastic Surgery ✕
4 devices
1-4 of 4
Cleared Jul 14, 2004
THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX
K040756 · FTM
General & Plastic Surgery · 112d
Cleared Oct 02, 2003
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330
K032344 · EZX
General & Plastic Surgery · 64d
Cleared Aug 21, 2003
MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
K032282 · EZX
General & Plastic Surgery · 28d
Cleared Feb 19, 2003
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
K023882 · EZX
General & Plastic Surgery · 90d
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