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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Universal Base Skull
Stryker Leibinger GmbH & Co. KG
8000-040-017
In Commercial Distribution

  • 07613327500509 ()
8000-040-017

  • Optical surgical navigation device tracking system
Spine Guidance 5 Sales Demo
Stryker Leibinger GmbH & Co. KG
81-81044
In Commercial Distribution

  • 07613327616286 ()
81-81044

  • Optical surgical navigation device tracking system
Spine Guidance 5 Enable
Stryker Leibinger GmbH & Co. KG
6002-810-300
In Commercial Distribution

  • 07613327616255 ()
6002-810-300

  • Optical surgical navigation device tracking system
Spine Guidance 5 Software
Stryker Leibinger GmbH & Co. KG
6002-810-000
In Commercial Distribution

  • 07613327616118 ()
6002-810-000

  • Optical surgical navigation device tracking system
Q Guidance System
Stryker Leibinger GmbH & Co. KG
8900-100-000
In Commercial Distribution

  • 07613327503265 ()
8900-100-000

  • Optical surgical navigation device tracking system
Spine Guidance 5 Update
Stryker Leibinger GmbH & Co. KG
6002-810-200
In Commercial Distribution

  • 07613327638196 ()
6002-810-200

  • Optical surgical navigation device tracking system
Spine Guidance 5 Upgrade
Stryker Leibinger GmbH & Co. KG
6002-810-100
In Commercial Distribution

  • 07613327638189 ()
6002-810-100

  • Optical surgical navigation device tracking system
Tracking Instrument Battery
Stryker Leibinger GmbH & Co. KG
700001577578
In Commercial Distribution

  • 07613327579888 ()
700001577578

  • Optical surgical navigation device tracking system
Tracker-70
Stryker Leibinger GmbH & Co. KG
700001577582
In Commercial Distribution

  • 07613327579833 ()
700001577582

  • Optical surgical navigation device tracking system
Stryker Ortho Q Guidance System
Stryker Leibinger GmbH & Co. KG
8800-100-000
In Commercial Distribution

  • 07613327576542 ()
8800-100-000

  • Optical surgical navigation device tracking system
PROFESS(TM) REGISTRATION KIT
Stryker Leibinger GmbH & Co. KG
6001-420-000
In Commercial Distribution

  • 07613252727057 ()
6001-420-000

  • Optical surgical navigation device tracking system
HOLO Calibration Tube, Pedicle Prep Ins
Surgalign Spine Technologies, Inc.
154000096
In Commercial Distribution

  • 00850028694428 ()


  • Optical surgical navigation device tracking system
HOLO ARAI System
Surgalign Spine Technologies, Inc.
154000100
In Commercial Distribution

  • 00850028694404 ()


  • Optical surgical navigation device tracking system
Holo AR Mirror, Sterile
Surgalign Spine Technologies, Inc.
154000074
In Commercial Distribution

  • 00850028694381 ()


  • Optical surgical navigation device tracking system
HOLO AR Glasses
Surgalign Spine Technologies, Inc.
154000053
In Commercial Distribution

  • 00850028694237 ()


  • Optical surgical navigation device tracking system
HOLO Patient Array
Surgalign Spine Technologies, Inc.
154000412
In Commercial Distribution

  • 00850028694633 ()


  • Optical surgical navigation device tracking system
HOLO AR Mirror Frame, Sterile
Surgalign Spine Technologies, Inc.
154000017
In Commercial Distribution

  • 00850028694015 ()


  • Optical surgical navigation device tracking system
Virtual-display arm rehabilitation system
SAEBO, INC.
SaeboRejoyce
In Commercial Distribution

  • 00850331006567 ()
K4-RJ-10---1

  • Virtual-display arm rehabilitation system, non-gravity-compensating
HOLO Calibration Tube, Screwdriver
Surgalign Spine Technologies, Inc.
155000007
In Commercial Distribution

  • 00840311242689 ()


  • Optical surgical navigation device tracking system
No Description
ECENTIAL ROBOTICS
I00026
In Commercial Distribution

  • 03701311501275 ()


  • Optical surgical navigation device tracking system
Tag adapter (adjustable)
Naviswiss AG
NS131
In Commercial Distribution

  • 07640176971310 ()


  • Optical surgical navigation device tracking system
Sterilization tray (metal, 145 x 44 x 25 mm)
Naviswiss AG
NS123
In Commercial Distribution

  • 07640176971235 ()


  • Optical surgical navigation device tracking system
Sterilization tray (metal, 485 x 250 x 105 mm)
Naviswiss AG
NS122
In Commercial Distribution

  • 07640176971228 ()


  • Optical surgical navigation device tracking system
Tag Adapter M (clamp)
Naviswiss AG
NS121
In Commercial Distribution

  • 07640176971211 ()


  • Optical surgical navigation device tracking system
Cup impactor adapter B
Naviswiss AG
NS120
In Commercial Distribution

  • 07640176971204 ()


  • Optical surgical navigation device tracking system
Pointer extension
Naviswiss AG
NS119
In Commercial Distribution

  • 07640176971198 ()


  • Optical surgical navigation device tracking system
Straight reamer adapter V
Naviswiss AG
NS116
In Commercial Distribution

  • 07640176971167 ()


  • Optical surgical navigation device tracking system
Cross coupling adapter
Naviswiss AG
NS107
In Commercial Distribution

  • 07640176971075 ()


  • Optical surgical navigation device tracking system
Tag adapter F (LP)
Naviswiss AG
NS098
In Commercial Distribution

  • 07640176970986 ()


  • Optical surgical navigation device tracking system
Single-pin tag mount (LP) (self-drilling, wear part)
Naviswiss AG
NS097
In Commercial Distribution

  • 07640176970979 ()


  • Optical surgical navigation device tracking system
Tablet computer holder
Naviswiss AG
NS096
In Commercial Distribution

  • 07640176970962 ()


  • Optical surgical navigation device tracking system
Navigation unit holder
Naviswiss AG
NS095
In Commercial Distribution

  • 07640176970955 ()


  • Optical surgical navigation device tracking system
Pointer (curved, sharp)
Naviswiss AG
NS094
In Commercial Distribution

  • 07640176970948 ()


  • Optical surgical navigation device tracking system
Tag adapter M straight (quick-lock)
Naviswiss AG
NS093
In Commercial Distribution

  • 07640176970931 ()


  • Optical surgical navigation device tracking system
Tablet computer
Naviswiss AG
NS090
In Commercial Distribution

  • 07640176970900 ()


  • Optical surgical navigation device tracking system
Articulated Arm
Naviswiss AG
NS089
In Commercial Distribution

  • 07640176970894 ()


  • Optical surgical navigation device tracking system
Sterilization tray (254 x 152 x 64 mm)
Naviswiss AG
NS085
In Commercial Distribution

  • 07640176970856 ()


  • Optical surgical navigation device tracking system
Screwdriver handle (AO coupling)
Naviswiss AG
NS083
In Commercial Distribution

  • 07640176970832 ()


  • Optical surgical navigation device tracking system
Hex screwdriver SW2.5mm
Naviswiss AG
NS082
In Commercial Distribution

  • 07640176970825 ()


  • Optical surgical navigation device tracking system
Shoulder pin (3.0 x 25mm, wear part)
Naviswiss AG
NS081
In Commercial Distribution

  • 07640176970818 ()


  • Optical surgical navigation device tracking system
Femur base handle
Naviswiss AG
NS080
In Commercial Distribution

  • 07640176970801 ()


  • Optical surgical navigation device tracking system
Femur base (adjustable)
Naviswiss AG
NS079
In Commercial Distribution

  • 07640176970795 ()


  • Optical surgical navigation device tracking system
Fixation plate tag holder
Naviswiss AG
NS077
In Commercial Distribution

  • 07640176970771 ()


  • Optical surgical navigation device tracking system
Fixation plate
Naviswiss AG
NS075
In Commercial Distribution

  • 07640176970757 ()


  • Optical surgical navigation device tracking system
Set of 2x Speed pin (3.0 x 80 mm, sterile, single use)
Naviswiss AG
NS068
In Commercial Distribution

  • 07640176970689 ()


  • Optical surgical navigation device tracking system
Single-pin tag mount short (self drilling, wear part)
Naviswiss AG
NS061
In Commercial Distribution

  • 07640176970610 ()


  • Optical surgical navigation device tracking system
Cutting block (1.27mm, adjustable)
Naviswiss AG
NS078
In Commercial Distribution

  • 07640176970788 ()


  • Optical surgical navigation device tracking system
Fixation plate inserter
Naviswiss AG
NS076
In Commercial Distribution

  • 07640176970764 ()


  • Optical surgical navigation device tracking system
Slot adapter
Naviswiss AG
NS073
In Commercial Distribution

  • 07640176970733 ()


  • Optical surgical navigation device tracking system
Set of 2x Speed pin (3.0 x 110 mm, sterile, single use)
Naviswiss AG
NS066
In Commercial Distribution

  • 07640176970665 ()


  • Optical surgical navigation device tracking system
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