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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 K092082
Device Name SYNERGY CANNULATED SCREW SYSTEM
Applicant
SYNERGY SURGICAL TECHNOLOGIES, LLC
11234 EL CAMINO REAL,
SUITE 200
SAN DIEGO,  CA  92130
Applicant Contact KEVIN THOMAS
Correspondent
SYNERGY SURGICAL TECHNOLOGIES, LLC
11234 EL CAMINO REAL,
SUITE 200
SAN DIEGO,  CA  92130
Correspondent Contact KEVIN THOMAS
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received07/09/2009
Decision Date 10/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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