FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

65 results for "Implex Corp."
1–24 of 65
Search insights Median review: 81d Cleared: 100% Top manufacturer: Implex Corp. Lead specialty: Orthopedic
Cleared Sep 23, 2005
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT
K051978 · MQP
Implex Corp.
Orthopedic · 64d
Cleared Jun 17, 2005
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1
K051196 · MQP
Implex Corp.
Orthopedic · 38d
Cleared Dec 21, 2004
TRABECULAR METAL KNEE SYSTEM AUGMENTS
K040487 · MBH
Implex Corp.
Orthopedic · 300d
Cleared Sep 30, 2004
TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ
K040630 · JWH
Implex Corp.
Orthopedic · 204d
Cleared Jul 14, 2004
THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX
K040756 · FTM
Implex Corp.
General & Plastic Surgery · 112d
Cleared Jan 08, 2004
NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS
K031962 · JWH
Implex Corp.
Orthopedic · 197d
Cleared Nov 19, 2003
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ
K033384 · JDK
Implex Corp.
Orthopedic · 27d
Cleared Oct 31, 2003
HEDROCEL VERTEBRAL BODY REPLACEMENT
K032527 · MQP
Implex Corp.
Orthopedic · 77d
Cleared Oct 02, 2003
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330
K032344 · EZX
Implex Corp.
General & Plastic Surgery · 64d
Cleared Sep 23, 2003
MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE...
K031449 · KWS
Implex Corp.
Orthopedic · 139d
Cleared Aug 21, 2003
MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
K032282 · EZX
Implex Corp.
General & Plastic Surgery · 28d
Cleared Aug 06, 2003
THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS
K031462 · MBH
Implex Corp.
Orthopedic · 90d
Cleared Jul 11, 2003
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
K031823 · MQP
Implex Corp.
Orthopedic · 28d
Cleared Feb 19, 2003
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
K023882 · EZX
Implex Corp.
General & Plastic Surgery · 90d
Cleared Jan 15, 2003
NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS
K024161 · JWH
Implex Corp.
Orthopedic · 29d
Cleared Dec 10, 2002
THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION,...
K022377 · KWT
Implex Corp.
Orthopedic · 141d
Cleared Oct 02, 2002
PROXILOCK HIP PROSTHESIS
K022966 · LWJ
Implex Corp.
Orthopedic · 26d
Cleared Aug 30, 2002
HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
K022563 · MQP
Implex Corp.
Orthopedic · 28d
Cleared Jul 17, 2002
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2
K021967 · MQP
Implex Corp.
Orthopedic · 30d
Cleared Jul 12, 2002
THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND...
K021970 · LPH
Implex Corp.
Orthopedic · 25d
Cleared May 20, 2002
MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
K021025 · MQP
Implex Corp.
Orthopedic · 52d
Cleared Feb 12, 2002
NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA
K020295 · JWH
Implex Corp.
Orthopedic · 15d
Cleared Jan 28, 2002
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
K010378 · MQP
Implex Corp.
Orthopedic · 354d
Cleared Sep 26, 2001
THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0
K012866 · JWH
Implex Corp.
Orthopedic · 30d