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FDA 510(k) Application Details - K183194
Device Classification Name
More FDA Info for this Device
510(K) Number
K183194
Device Name
Arthrex Eclipse Shoulder Prosthesis System
Applicant
Arthrex Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 US
Other 510(k) Applications for this Company
Contact
David L Rogers
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QHQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/19/2018
Decision Date
07/26/2019
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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