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. Orthopedic ✕

61 devices

1-12 of 61

Cleared Sep 23, 2005

TRABECULAR METAL VERTEBRAL BODY REPLACEMENT

Orthopedic · 64d

Cleared Jun 17, 2005

TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1

Orthopedic · 38d

Cleared Dec 21, 2004

TRABECULAR METAL KNEE SYSTEM AUGMENTS

Orthopedic · 300d

Cleared Sep 30, 2004

TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ

Orthopedic · 204d

Cleared Jan 08, 2004

NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS

Orthopedic · 197d

Cleared Nov 19, 2003

THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ

Orthopedic · 27d

Cleared Oct 31, 2003

HEDROCEL VERTEBRAL BODY REPLACEMENT

Orthopedic · 77d

Cleared Sep 23, 2003

MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE...

Orthopedic · 139d

Cleared Aug 06, 2003

THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS

Orthopedic · 90d

Cleared Jul 11, 2003

HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1

Orthopedic · 28d

Cleared Jan 15, 2003

NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS

Orthopedic · 29d

Cleared Dec 10, 2002

THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION,...

Orthopedic · 141d

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