Medical Device Manufacturer · FR , Viriat

Fx Solutions - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2011
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Fx Solutions Orthopedic ✕
8 devices
1-8 of 8
Cleared May 17, 2017
Humeris Shoulder
K163669 · PHX
Orthopedic · 141d
Cleared Jan 17, 2017
Humelock Reversed Shoulder
K162455 · PHX
Orthopedic · 137d
Cleared Nov 13, 2015
Humelock II Reversible Shoulder System
K150488 · PHX
Orthopedic · 261d
Cleared Aug 27, 2015
PRCT2
K143721 · HRS
Orthopedic · 241d
Cleared Jul 28, 2014
HUMELOCK II CEMENTED SHOULDER SYSTEM
K140071 · KWT
Orthopedic · 196d
Cleared Nov 09, 2013
HUMELOCK II CEMENTLESS SHOULDER SYSTEM
K130759 · HSD
Orthopedic · 234d
Cleared Aug 13, 2013
HUMELOCK II CEMENTED SHOULDER SYSTEM
K123814 · KWT
Orthopedic · 244d
Cleared Nov 09, 2011
HUMELOCK CEMENTED SHOULDER PROSTHESIS
K111097 · HSD
Orthopedic · 203d
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