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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K080943
Device Name SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS
Applicant
Synthes (Usa)
1301 Goshen Pkwy.
19380,  PA  19380
Applicant Contact SHERI L MUSGNUNG
Correspondent
Synthes (Usa)
1301 Goshen Pkwy.
19380,  PA  19380
Correspondent Contact SHERI L MUSGNUNG
Regulation Number888.3040
Classification Product Code
HWC  
Date Received04/03/2008
Decision Date 04/23/2008
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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