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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 K955848
Device Name ORTHOFIX MODULSYSTEM
Applicant
Orthofix, Inc.
12300 Twinbrook Pkwy., Suite 625
Rockville,  MD  20852
Applicant Contact ROBERT L SHERIDAN
Correspondent
Orthofix, Inc.
12300 Twinbrook Pkwy., Suite 625
Rockville,  MD  20852
Correspondent Contact ROBERT L SHERIDAN
Regulation Number888.3040
Classification Product Code
JDW  
Date Received12/27/1995
Decision Date 03/20/1996
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
Recalls CDRH Recalls
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