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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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n/a - 07613327467215

Tracker Sleeve
Stryker Leibinger GmbH & Co. KG
6000-803-000
In Commercial Distribution

  • 07613327467215 ()
6000-803-000

  • Surgical planning/navigation-enhancement system

n/a - 07613327467208

Precision Targeting Guide
Stryker Leibinger GmbH & Co. KG
6000-802-000
In Commercial Distribution

  • 07613327467208 ()
6000-802-000

  • Surgical planning/navigation-enhancement system

Black Diamond Pedicle Screw System - B06210101550

TUBE ROD BENDER, BLK DIAMOND
Osseus Fusion Systems, LLC
1010-1550
In Commercial Distribution

  • B06210101550 ()
1010-1550

  • Spinal rod bending system

Black Diamond Pedicle Screw System - B06210101400

IN-SITU BENDERS, BLK DIAMOND
Osseus Fusion Systems, LLC
1010-1400
In Commercial Distribution

  • B06210101400 ()
1010-1400

  • Spinal rod bending system

Black Diamond Pedicle Screw System - B06210101017

ROD BENDER, BLK DIAMOND
Osseus Fusion Systems, LLC
1010-1017
In Commercial Distribution

  • B06210101017 ()
1010-1017

  • Spinal rod bending system

X-Guide - 00817421022791

EDX-S Tracker Arm, Vertical, Center
XNAV TECHNOLOGIES LLC
P011803
In Commercial Distribution

  • 00817421022791 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022647

EDX-S Tracker Arm, Horizontal, Right
XNAV TECHNOLOGIES LLC
P010873
In Commercial Distribution

  • 00817421022647 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022630

EDX-S Tracker Arm, Vertical, Right
XNAV TECHNOLOGIES LLC
P010869
In Commercial Distribution

  • 00817421022630 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022623

EDX-S Tracker Arm, Horizontal, Left
XNAV TECHNOLOGIES LLC
P010874
In Commercial Distribution

  • 00817421022623 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022616

EDX-S Tracker Arm, Vertical, Left
XNAV TECHNOLOGIES LLC
P010870
In Commercial Distribution

  • 00817421022616 ()


  • Surgical planning/navigation-enhancement system
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