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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Threaded
510(k) Number K061493
Device Name APEX PINS
Applicant
Stryker Howmedica Osteonics
325 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact VIVIAN KELLY
Correspondent
Stryker Howmedica Osteonics
325 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact VIVIAN KELLY
Regulation Number888.3040
Classification Product Code
JDW  
Date Received05/31/2006
Decision Date 07/07/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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