Medical Device Manufacturer · US , Irvine , CA

Phygen, LLC - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2011
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Phygen, LLC Orthopedic ✕
7 devices
1-7 of 7
Cleared Mar 07, 2012
LEUCADIA 4.5 MM PEDICLE SCREW SYSTEM
K120355 · NKB
Orthopedic · 30d
Cleared Jan 17, 2012
LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM
K113366 · NKB
Orthopedic · 63d
Cleared Nov 02, 2011
LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM
K112931 · NKB
Orthopedic · 30d
Cleared Aug 02, 2011
DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM
K110679 · NKB
Orthopedic · 145d
Cleared May 25, 2011
LEUCADIA PEDICLE SCREW SYSTEM
K110588 · NKB
Orthopedic · 84d
Cleared Mar 02, 2011
LAGUNA PEDICLE SCREW SYSTEM
K103748 · NKB
Orthopedic · 69d
Cleared Feb 08, 2011
LEUCADIA PEDICLE SCREW SYSTEM
K103102 · MNI
Orthopedic · 111d
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