VANGUARD REMOVABLE MOLDED POLY TIBIA

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

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Vanguard Removable Molded Poly Tibia.

Pre-market Notification Details

• Device ID: K060525
• 510k Number: K060525
• Device Name: VANGUARD REMOVABLE MOLDED POLY TIBIA
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw, IN 46581 -0587
• Contact: Tracy Bickel Johnson
• Correspondent: Tracy Bickel Johnson; BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO 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: 2006-02-27
• Decision Date: 2006-05-25
• Summary: summary

NIH GUDID Devices

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