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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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CD HORIZON® SOLERA® VOYAGER™ Spinal System - 00643169784284

SCREW 55850016095 5.5 VOYAGER MAS 6.0X95
MEDTRONIC SOFAMOR DANEK, INC.
55850016095
Not in Commercial Distribution

  • 00643169784284 ()

  • Outer Diameter: 6.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

CD HORIZON® SOLERA® VOYAGER™ Spinal System - 00643169784277

SCREW 55850016090 5.5 VOYAGER MAS 6.0X90
MEDTRONIC SOFAMOR DANEK, INC.
55850016090
Not in Commercial Distribution

  • 00643169784277 ()

  • Outer Diameter: 6.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

CD HORIZON® SOLERA® VOYAGER™ Spinal System - 00643169784260

SCREW 55850016085 5.5 VOYAGER MAS 6.0X85
MEDTRONIC SOFAMOR DANEK, INC.
55850016085
Not in Commercial Distribution

  • 00643169784260 ()

  • Outer Diameter: 6.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

CD HORIZON® SOLERA® VOYAGER™ Spinal System - 00643169784253

SCREW 55850016080 5.5 VOYAGER MAS 6.0X80
MEDTRONIC SOFAMOR DANEK, INC.
55850016080
Not in Commercial Distribution

  • 00643169784253 ()

  • Outer Diameter: 6.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

CD HORIZON® SOLERA® VOYAGER™ Spinal System - 00643169784246

SCREW 55850016075 5.5 VOYAGER MAS 6.0X75
MEDTRONIC SOFAMOR DANEK, INC.
55850016075
Not in Commercial Distribution

  • 00643169784246 ()

  • Outer Diameter: 6.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

CD HORIZON® SOLERA® VOYAGER™ Spinal System - 00643169784239

SCREW 55850016070 5.5 VOYAGER MAS 6.0X70
MEDTRONIC SOFAMOR DANEK, INC.
55850016070
Not in Commercial Distribution

  • 00643169784239 ()

  • Outer Diameter: 6.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

CD HORIZON® SOLERA® VOYAGER™ Spinal System - 00643169784222

SCREW 55850016065 5.5 VOYAGER MAS 6.0X65
MEDTRONIC SOFAMOR DANEK, INC.
55850016065
Not in Commercial Distribution

  • 00643169784222 ()

  • Outer Diameter: 6.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

CD HORIZON® SOLERA® VOYAGER™ Spinal System - 00643169784215

SCREW 55850016060 5.5 VOYAGER MAS 6.0X60
MEDTRONIC SOFAMOR DANEK, INC.
55850016060
Not in Commercial Distribution

  • 00643169784215 ()

  • Outer Diameter: 6.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

HR Walkway VersaTek - B970HRV20

Includes 4 VersaTek Cuffs, 2 VersaTek 2-Port Hubs, 2 Power Supplies, (1) 4-Port Powered USB Hub, Walkway Software CD with 7101D Map with 3 Equilibration Files, Help File and PDF of System Manual, 2 HR Mat 7101E Sensors (pre-assembled into a single floor display), Hub Enclosure, Wooden Shipping Crate, and 1 Training Session (USA Only)
Tekscan, Inc.
HR Walkway 2 VersaTek System
In Commercial Distribution

  • B970HRV20 ()
HRV2

  • Body-surface pressure mapping system

HR Mat VersaTek - B970HRV10

Includes 2 VersaTek Cuffs, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, Linking Cable, FootMat Software for Clinicians CD with 7101E Map, Help File and PDF of System Manual, HR Mat 7101E Sensor installed in floor display, 10 ft. USB Cable, (2) 10 ft. Cuff Cables, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
HR Mat VersaTek Platform with FootMat Software for Clinicians
In Commercial Distribution

  • B970HRV10 ()
HRV1

  • Body-surface pressure mapping system
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