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FDA 510(k) Application Details - K110592
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K110592
Device Name
Screw, Fixation, Bone
Applicant
SYNTHES USA
1301 GOSHEN PKWY
WEST CHESTER, PA 19380 US
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Contact
CHRISTOPHER HACK, ESQ
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/02/2011
Decision Date
07/25/2011
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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