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FDA 510(k) Application Details - K133785
Device Classification Name
Cerclage, Fixation
More FDA Info for this Device
510(K) Number
K133785
Device Name
Cerclage, Fixation
Applicant
PIONEER SURGICAL TECHNOLOGY, INC
375 RIVER PARK CIRCLE
MARQUETTE, MI 49855 US
Other 510(k) Applications for this Company
Contact
EMILY DOWNS
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
12/12/2013
Decision Date
01/27/2014
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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