NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

IMPLEX CORP.

The following data is part of a premarket notification filed by Implex Corp. with the FDA for Nexgen Complete Knee Solution - Trabecular Metal Augments.

Pre-market Notification Details

• Device ID: K024161
• 510k Number: K024161
• Device Name: NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600
• Contact: Marci Halevi
• Correspondent: Marci Halevi; IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-12-17
• Decision Date: 2003-01-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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