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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K102992
Device Name T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES
Applicant
Howmedica Osteonics Corp.
325 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact AVITAL MERL-MARGULIES
Correspondent
Howmedica Osteonics Corp.
325 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact AVITAL MERL-MARGULIES
Regulation Number888.3020
Classification Product Code
HSB  
Date Received10/08/2010
Decision Date 12/22/2010
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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