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FDA 510(k) Application Details - K191426
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K191426
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
Arthrex Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 US
Other 510(k) Applications for this Company
Contact
Ivette Galmez
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
05/29/2019
Decision Date
11/26/2019
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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