VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS

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

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Vanguard Anterior Stabilized Tibial Bearings.

Pre-market Notification Details

• Device ID: K050222
• 510k Number: K050222
• Device Name: VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS
• Classification: Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, 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: MBH
• CFR Regulation Number: 888.3565 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-01-31
• Decision Date: 2005-08-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00880304653443	K050222	000
00880304437012	K050222	000
00880304437029	K050222	000
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