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FDA 510(k) Application Details - K181076
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K181076
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
Responsive Arthroscopy LLC
701 N. 3rd Street, Suite 202
Minneapolis, MN 55401 US
Other 510(k) Applications for this Company
Contact
Doug Kohrs
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
04/24/2018
Decision Date
01/18/2019
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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