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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 Drive
Mahwah,  NJ  07430
Applicant Contact AVITAL MERL-MARGULIES
Correspondent
HOWMEDICA OSTEONICS CORP.
325 Corporate Drive
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
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