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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, shoulder, semi-constrained, metal/polymer, uncemented
510(k) Number K183553
Device Name Compress and Mini Compress Anti-Rotation Spindles
Applicant
Biomet, Inc
56 East Bell Drive
warsaw,  IN  46581
Applicant Contact michael mcburney
Correspondent
Biomet, Inc
56 East Bell Drive
warsaw,  IN  46581
Correspondent Contact michael mcburney
Regulation Number888.3670
Classification Product Code
MBF  
Subsequent Product Codes
JDC   JDI   KRO   KWS   KWT  
KWY   KWZ   LPH   LZO   MEH  
Date Received12/20/2018
Decision Date 01/22/2019
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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