VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL

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 Xp Femoral Component(gen Ii)/vanguard Xp Femoral Trial.

Pre-market Notification Details

• Device ID: K141407
• 510k Number: K141407
• Device Name: VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL
• 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: Julie Gantenberg, M.s.
• Correspondent: Julie Gantenberg, M.s.; BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587
• Product Code: MBH
• Subsequent Product Code: JWH
• Subsequent Product Code: MBV
• Subsequent Product Code: OIY
• CFR Regulation Number: 888.3565 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-05-28
• Decision Date: 2014-10-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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