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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
510(k) Number K150522
Device Name G7 Dual Mobility System
Applicant
BIOMET, INC.
56 EAST BELL DRIVE
WARSAW,  IN  46581
Applicant Contact Amy Walriven
Correspondent
BIOMET, INC.
56 EAST BELL DRIVE
WARSAW,  IN  46581
Correspondent Contact Amy Walriven
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
KWY   LZO   OQG  
Date Received03/02/2015
Decision Date 05/01/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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