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FDA 510(k) Application Details - K193468
Device Classification Name
Cerclage, Fixation
More FDA Info for this Device
510(K) Number
K193468
Device Name
Cerclage, Fixation
Applicant
Pioneer Surgical Technology, Inc. (dba RTI Surgical, Inc.)
375 River Park Circle
Marquette, MI 49855 US
Other 510(k) Applications for this Company
Contact
Linda Busklein
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
12/16/2019
Decision Date
03/12/2020
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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