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FDA 510(k) Application Details - K193394
Device Classification Name
More FDA Info for this Device
510(K) Number
K193394
Device Name
Humeral Cup Stability & Humeral Cup 135/145o Stability
Applicant
FX Shoulder USA, Inc.
13465 Midway Road, Suite 101
Dallas, TX 75244 US
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Contact
Kathy Trier
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PHX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/06/2019
Decision Date
04/29/2020
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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