NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS

Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Nexgen Porous, Uncemented Femoral And Tibial Baseplate Components.

Pre-market Notification Details

• Device ID: K031061
• 510k Number: K031061
• Device Name: NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS
• Classification: Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
• Applicant: ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Contact: Stephen Mckelvey
• Correspondent: Stephen Mckelvey; ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Product Code: MBH
• CFR Regulation Number: 888.3565 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-04-03
• Decision Date: 2003-10-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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