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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 K093762
Device Name SYNTHES ZERO-P
Applicant
Synthes Spine
1302 Wrights Ln. E.
West Chester,  PA  19380
Applicant Contact AMNON TALMOR
Correspondent
Synthes Spine
1302 Wrights Ln. E.
West Chester,  PA  19380
Correspondent Contact AMNON TALMOR
Regulation Number888.3080
Classification Product Code
OVE  
Date Received12/07/2009
Decision Date 12/20/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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