AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN

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 Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim Accel Knee System Also Known.

Pre-market Notification Details

• Device ID: K033489
• 510k Number: K033489
• Device Name: AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN
• Classification: Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
• Applicant: BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587
• Contact: Patricia Sandborn Beres
• Correspondent: Patricia Sandborn Beres; BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587
• Product Code: MBH
• CFR Regulation Number: 888.3565 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-11-04
• Decision Date: 2004-06-02
• Summary: summary

NIH GUDID Devices

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