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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/ceramic/polymer, cemented or non-porous, uncemented
510(k) Number K141653
Device Name BIOLOX DELTA CERAMIC OPTION HEADS
Applicant
BIOMET, INC.
56 EAST BELL DR.
BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact BECKY EARL
Correspondent
BIOMET, INC.
56 EAST BELL DR.
BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact BECKY EARL
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   LPH   LWJ   MAY   OQG  
OQH   OQI  
Date Received06/20/2014
Decision Date 08/18/2014
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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