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FDA 510(k) Application Details - K122074
Device Classification Name
More FDA Info for this Device
510(K) Number
K122074
Device Name
IFUSE IMPLANT SYSTEM
Applicant
SI-BONE, INC.
3055 OLIN AVE.
SUITE 2200
SAN JOSE, CA 95128 US
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Contact
CINDY DOMECUS
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OUR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/16/2012
Decision Date
10/12/2012
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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