COMPRESS DISTAL FEMORAL REPLACEMENT

Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Compress Distal Femoral Replacement.

Pre-market Notification Details

• Device ID: K031804
• 510k Number: K031804
• Device Name: COMPRESS DISTAL FEMORAL REPLACEMENT
• Classification: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
• Applicant: BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587
• Contact: Gary Baker
• Correspondent: Gary Baker; BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587
• Product Code: KRO
• CFR Regulation Number: 888.3510 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-06-11
• Decision Date: 2003-12-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00880304452497	K031804	000
00880304260542	K031804	000
00880304260535	K031804	000
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00880304259690	K031804	000
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00880304002883	K031804	000