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FDA 510(k) Application Details - K213117
Device Classification Name
More FDA Info for this Device
510(K) Number
K213117
Device Name
FX V135 Shoulder Prosthesis
Applicant
FX Shoulder USA, Inc.
13465 Midway Road, Suite 101
Dallas, TX 75244 US
Other 510(k) Applications for this Company
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
09/27/2021
Decision Date
06/07/2022
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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