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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
Recalls CDRH Recalls
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