NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO)

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 Primary Porous Patella, Model 04-211-iiii-5878-65-zz-(standard),04-212-iiii-5878-61-zz-(micro).

Pre-market Notification Details

• Device ID: K011904
• 510k Number: K011904
• Device Name: NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO)
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600
• Contact: Robert A Poggie
• Correspondent: Robert A Poggie; 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: 2001-06-19
• Decision Date: 2001-07-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889024465664	K011904	000
00889024309838	K011904	000
00889024309821	K011904	000
00889024309814	K011904	000
00889024309807	K011904	000