PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,

Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Prelude Pf Femoral Components (mim Cocrmo), Prelude Pf Femoral Components (cast Cocrmo), Prelude Pf Patella Components,.

Pre-market Notification Details

• Device ID: K123907
• 510k Number: K123907
• Device Name: PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,
• Classification: Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
• Applicant: BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587
• Contact: Elizabeth Wray
• Correspondent: Elizabeth Wray; BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587
• Product Code: KRR
• CFR Regulation Number: 888.3540 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-12-19
• Decision Date: 2013-09-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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