Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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PROBE TOOL
XNAV TECHNOLOGIES LLC
P008886
In Commercial Distribution

  • 00817421020230 ()
P008886

  • Surgical planning/navigation-enhancement system
SCREW DRIVER
XNAV TECHNOLOGIES LLC
P007842
In Commercial Distribution

  • 00817421020223 ()
P007842

  • Surgical planning/navigation-enhancement system
TRACKER ARM - LEFT
XNAV TECHNOLOGIES LLC
P008802
Not in Commercial Distribution

  • 00817421020216 ()
P008802

  • Surgical planning/navigation-enhancement system
TRACKER ARM - RIGHT
XNAV TECHNOLOGIES LLC
P008800
Not in Commercial Distribution

  • 00817421020209 ()
P008800

  • Surgical planning/navigation-enhancement system
TRACKER ARM - UNIVERSAL
XNAV TECHNOLOGIES LLC
P007505
In Commercial Distribution

  • 00817421020193 ()
P007505

  • Surgical planning/navigation-enhancement system
GO PLATE
XNAV TECHNOLOGIES LLC
P008641
In Commercial Distribution

  • 00817421020179 ()
P008641

  • Surgical planning/navigation-enhancement system
PATIENT TRACKER
XNAV TECHNOLOGIES LLC
P007652
In Commercial Distribution

  • 00817421020162 ()
P007652

  • Surgical planning/navigation-enhancement system
PROBE TOOL TRACKER
XNAV TECHNOLOGIES LLC
P009181
In Commercial Distribution

  • 00817421020155 ()
P009181

  • Surgical planning/navigation-enhancement system
HANDPIECE TRACKER
XNAV TECHNOLOGIES LLC
P007640
In Commercial Distribution

  • 00817421020148 ()
P007640

  • Surgical planning/navigation-enhancement system
INSTRUMENT KIT
XNAV TECHNOLOGIES LLC
P008818
In Commercial Distribution

  • 00817421020131 ()
P008818

  • Surgical planning/navigation-enhancement system
X-CLIP - PRACTICE
XNAV TECHNOLOGIES LLC
P007793
In Commercial Distribution

  • 00817421020124 ()
  • 00817421020544 ()
P007793

  • Surgical planning/navigation-enhancement system
X-GUIDE TRAINING KIT
XNAV TECHNOLOGIES LLC
P008930
In Commercial Distribution

  • 00817421020117 ()
P008930

  • Surgical planning/navigation-enhancement system
X-GUIDE USER MANUAL, ENGLISH
XNAV TECHNOLOGIES LLC
P007593
In Commercial Distribution

  • 00817421020100 ()
P007593

  • Surgical planning/navigation-enhancement system
X-GUIDE REGION KIT - U.K. / IRELAND, ENGLISH
XNAV TECHNOLOGIES LLC
P009137
Not in Commercial Distribution

  • 00817421020070 ()
P009137

  • Surgical planning/navigation-enhancement system
X-GUIDE REGION KIT - NORTH AMERICA, ENGLISH
XNAV TECHNOLOGIES LLC
P009081
In Commercial Distribution

  • 00817421020063 ()
P009081

  • Surgical planning/navigation-enhancement system
CART TRAY KIT
XNAV TECHNOLOGIES LLC
P009186
In Commercial Distribution

  • 00817421020056 ()
P009186

  • Surgical planning/navigation-enhancement system
X-GUIDE (United States)
XNAV TECHNOLOGIES LLC
P007839
In Commercial Distribution

  • 00817421020025 ()
  • 00817421022074 ()
P007839

  • Surgical planning/navigation-enhancement system
X-GUIDE PLANNING SOFTWARE - MAC OS
XNAV TECHNOLOGIES LLC
P008526
In Commercial Distribution

  • 00817421020018 ()
P008526

  • Surgical planning/navigation-enhancement system
X-GUIDE PLANNING SOFTWARE - MS WINDOWS
XNAV TECHNOLOGIES LLC
P008296
In Commercial Distribution

  • 00817421020001 ()
P008296

  • Surgical planning/navigation-enhancement system
ADAPTOR SLEEVE - 11
XNAV TECHNOLOGIES LLC
P010728
In Commercial Distribution

  • 00817421021589 ()


  • Surgical planning/navigation-enhancement system
ADAPTOR SLEEVE - 10
XNAV TECHNOLOGIES LLC
P010726
In Commercial Distribution

  • 00817421021572 ()


  • Surgical planning/navigation-enhancement system
ADAPTOR SLEEVE - 9
XNAV TECHNOLOGIES LLC
P010725
In Commercial Distribution

  • 00817421021565 ()


  • Surgical planning/navigation-enhancement system
ADAPTOR SLEEVE - 8
XNAV TECHNOLOGIES LLC
P010723
In Commercial Distribution

  • 00817421021558 ()


  • Surgical planning/navigation-enhancement system
ADAPTOR SLEEVE - 7
XNAV TECHNOLOGIES LLC
P010722
In Commercial Distribution

  • 00817421021541 ()


  • Surgical planning/navigation-enhancement system
ADAPTOR SLEEVE - 6
XNAV TECHNOLOGIES LLC
P010721
In Commercial Distribution

  • 00817421021534 ()


  • Surgical planning/navigation-enhancement system
ADAPTOR SLEEVE - 5
XNAV TECHNOLOGIES LLC
P010720
In Commercial Distribution

  • 00817421021527 ()


  • Surgical planning/navigation-enhancement system
ADAPTOR SLEEVE - 4
XNAV TECHNOLOGIES LLC
P010719
In Commercial Distribution

  • 00817421021510 ()


  • Surgical planning/navigation-enhancement system
ADAPTOR SLEEVE - 3
XNAV TECHNOLOGIES LLC
P010727
In Commercial Distribution

  • 00817421021503 ()


  • Surgical planning/navigation-enhancement system
ADAPTOR SLEEVE - 2
XNAV TECHNOLOGIES LLC
P010724
In Commercial Distribution

  • 00817421021497 ()


  • Surgical planning/navigation-enhancement system
ADAPTOR SLEEVE - 1
XNAV TECHNOLOGIES LLC
P010701
In Commercial Distribution

  • 00817421021480 ()


  • Surgical planning/navigation-enhancement system
EDX Nut Driver
XNAV TECHNOLOGIES LLC
P010859
In Commercial Distribution

  • 00817421021473 ()
P010859

  • Surgical planning/navigation-enhancement system
TRACKER ARM ASSEMBLY, EDX, ANTERIOR LL
XNAV TECHNOLOGIES LLC
P010876
In Commercial Distribution

  • 00817421021282 ()


  • Surgical planning/navigation-enhancement system
TRACKER ARM ASSEMBLY, EDX, ANTERIOR LR
XNAV TECHNOLOGIES LLC
P010875
In Commercial Distribution

  • 00817421021275 ()


  • Surgical planning/navigation-enhancement system
TRACKER ARM ASSEMBLY, EDX, POSTERIOR LL
XNAV TECHNOLOGIES LLC
P010874
Not in Commercial Distribution

  • 00817421021268 ()


  • Surgical planning/navigation-enhancement system
TRACKER ARM ASSEMBLY, EDX, POSTERIOR LR
XNAV TECHNOLOGIES LLC
P010873
Not in Commercial Distribution

  • 00817421021251 ()


  • Surgical planning/navigation-enhancement system
TRACKER ARM ASSEMBLY, EDX, ANTERIOR UL
XNAV TECHNOLOGIES LLC
P010872
In Commercial Distribution

  • 00817421021244 ()


  • Surgical planning/navigation-enhancement system
TRACKER ARM ASSEMBLY, EDX, ANTERIOR UR
XNAV TECHNOLOGIES LLC
P010871
In Commercial Distribution

  • 00817421021237 ()


  • Surgical planning/navigation-enhancement system
TRACKER ARM ASSEMBLY, EDX, POSTERIOR UL
XNAV TECHNOLOGIES LLC
P010870
Not in Commercial Distribution

  • 00817421021220 ()


  • Surgical planning/navigation-enhancement system
TRACKER ARM ASSEMBLY, EDX, POSTERIOR UR
XNAV TECHNOLOGIES LLC
P010869
Not in Commercial Distribution

  • 00817421021213 ()


  • Surgical planning/navigation-enhancement system
EDX-C TRACKER ARM, UPPER
XNAV TECHNOLOGIES LLC
P010860
In Commercial Distribution

  • 00817421021206 ()


  • Surgical planning/navigation-enhancement system
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