VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS

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

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Vanguard Knee System Titanium Femoral Components.

Pre-market Notification Details

• Device ID: K080204
• 510k Number: K080204
• Device Name: VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587
• Contact: Gary Baker
• Correspondent: Gary Baker; BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-01-28
• Decision Date: 2008-03-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00880304476844	K080204	000
00880304653245	K080204	000
00880304653481	K080204	000
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