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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, cemented
510(k) Number K141331
Device Name BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)
Applicant
BIOMET, INC.
56 EAST BELL DRIVE
PO BOX 587
WARSAW,  IN  46581
Applicant Contact TRACY BICKEL JOHNSON
Correspondent
BIOMET, INC.
56 EAST BELL DRIVE
PO BOX 587
WARSAW,  IN  46581
Correspondent Contact TRACY BICKEL JOHNSON
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
KRO   LPH  
Date Received05/21/2014
Decision Date 10/27/2014
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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