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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name staple, fixation, bone
510(k) Number K141550
Device Name INSTAFIX SHAPE MEMORY FIXATION SYSTEM
Applicant
OT MEDICAL
1000 CONTINENTAL DRIVE, SUITE 240
KING OF PRUSSIA,  PA  19406
Applicant Contact WILLIAM RHODA
Correspondent
OT MEDICAL
1000 CONTINENTAL DRIVE, SUITE 240
KING OF PRUSSIA,  PA  19406
Correspondent Contact WILLIAM RHODA
Regulation Number888.3030
Classification Product Code
JDR  
Date Received06/11/2014
Decision Date 07/11/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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