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FDA 510(k) Application Details - K171060
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K171060
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
Riverpoint Medical
825 NE 25TH Avenue
Portland, OR 97232 US
Other 510(k) Applications for this Company
Contact
Nathan Cook
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
MBI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/10/2017
Decision Date
06/02/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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