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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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PRECICE® Specialty Targeting Instrument Set - 00812258026394

Surgical instrument tray containing orthopedic surgical instruments - for use with the intramedullary limb lengthening rod system
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ITA4-000
In Commercial Distribution

  • 00812258026394 ()

  • tool/instrument
ITA4-000

  • General internal orthopaedic fixation system implantation kit

FREEDOM Residual Limb Lengthening System - 00812258026370

Surgical instrument tray containing orthopedic surgical instruments - for use with the residual limb lengthening rod system
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ITR1-000
In Commercial Distribution

  • 00812258026370 ()

  • tool/instrument
ITR1-000

  • General internal orthopaedic fixation system implantation kit

PRECICE® Instrument Set - 00812258022327

Surgical instrument tray containing orthopedic surgical instruments - for use with the intramedullary limb lengthening rod system
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ITA2-000
In Commercial Distribution

  • 00812258022327 ()

  • tool/instrument
ITA2-000

  • General internal orthopaedic fixation system implantation kit

PRECICE® Instrument Set - 00812258021740

Surgical instrument tray containing orthopedic surgical instruments - for use with the intramedullary limb lengthening rod system
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ATA1-000
In Commercial Distribution

  • 00812258021740 ()

  • tool/instrument
ATA1-000

  • General internal orthopaedic fixation system implantation kit

PRECICE® Instrument Set - 00812258021733

Surgical instrument tray containing orthopedic surgical instruments - for use with the intramedullary limb lengthening rod system
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ITA1-000
In Commercial Distribution

  • 00812258021733 ()

  • tool/instrument
ITA1-000

  • General internal orthopaedic fixation system implantation kit

BIORAPTOR - 03596010595546

INLINE DRILL BIT 2.9 MM, SUITABLE FOR USE WITH KINSA ANCHOR AND BIORAPTOR 2.9 MM ANCHORS
Smith & Nephew, Inc.
72201395
In Commercial Distribution

  • 03596010595546 ()
72201395

  • General internal orthopaedic fixation system implantation kit

QWIX - 10381780064442

The QWIX positioning and fixation screw are designed to provide speed and precision for challenging surgical situations. They are indicated for fixation of bone fractures or for bone reconstructions. QWIX 3.0 and 4.3 are designed with self-drilling flutes. The compression screw has a non-threaded shaft and a self-tapping screw tip. Instruments are also provided.
NEWDEAL
QWX34INSTSET
Not in Commercial Distribution

  • 10381780064442 ()
  • M248QWX34INSTSET1 ()
QWX34INSTSET

  • General internal orthopaedic fixation system implantation kit

Trigon - 00810005669771

8mm (2° Sagittal 8° Transverse) Lapidus Wedge . The Trigon HA Stand-Alone Wedge Fixagtion System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
LD-080208T-28
In Commercial Distribution

  • 00810005669771 ()

  • Height: 8 Millimeter


  • General internal orthopaedic fixation system implantation kit

Trigon - 00810005669764

8mm (2° Sagittal 6° Transverse) Lapidus Wedge . The Trigon HA Stand-Alone Wedge Fixagtion System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
LD-080206T-28
In Commercial Distribution

  • 00810005669764 ()

  • Height: 8 Millimeter


  • General internal orthopaedic fixation system implantation kit

Trigon - 00810005669757

8mm (2° Sagittal 4° Transverse) Lapidus Wedge . The Trigon HA Stand-Alone Wedge Fixagtion System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
LD-080204T-28
In Commercial Distribution

  • 00810005669757 ()

  • Height: 8 Millimeter


  • General internal orthopaedic fixation system implantation kit
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