Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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