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FDA 510(k) Application Details - K110789
Device Classification Name
Cerclage, Fixation
More FDA Info for this Device
510(K) Number
K110789
Device Name
Cerclage, Fixation
Applicant
SYNTHES (USA)
1301 GOSHEN PARKWYA
WEST CHESTER, PA 19380 US
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Contact
ANDREA M TASKER
Other 510(k) Applications for this Contact
Regulation Number
888.3010
More FDA Info for this Regulation Number
Classification Product Code
JDQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/22/2011
Decision Date
07/28/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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