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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with integrated fixation, cervical
510(k) Number K112459
Device Name SYNTHES ZERO-P
Applicant
SYNTHES SPINE CO.LP
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Applicant Contact STACEY BONNELL
Correspondent
SYNTHES SPINE CO.LP
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Correspondent Contact STACEY BONNELL
Regulation Number888.3080
Classification Product Code
OVE  
Date Received08/26/2011
Decision Date 12/12/2011
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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