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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name screw, fixation, bone
510(k) Number K002654
Device Name HOWMEDICA OSTEONICS SHOULDER SCREW
Applicant
HOWMEDICA OSTEONICS CORP.
359 VETERANS BLVD.
RUTHERFORD,  NJ  07070 -2584
Applicant Contact JENNIFER A DAUDELIN
Correspondent
HOWMEDICA OSTEONICS CORP.
359 VETERANS BLVD.
RUTHERFORD,  NJ  07070 -2584
Correspondent Contact JENNIFER A DAUDELIN
Regulation Number888.3040
Classification Product Code
HWC  
Date Received08/25/2000
Decision Date 09/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
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