IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY

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 Implex Continuum Knee System-patellar Components, Model 04-xx-yyyyy.

Pre-market Notification Details

• Device ID: K004013
• 510k Number: K004013
• Device Name: IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600
• Contact: John Schalago
• Correspondent: John Schalago; 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: 2000-12-27
• Decision Date: 2001-01-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889024309678	K004013	000
00889024309661	K004013	000
00889024309654	K004013	000
00889024309647	K004013	000