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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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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-24
In Commercial Distribution

  • 00810005666794 ()

  • Height: 8 Millimeter


  • General internal orthopaedic fixation system implantation kit
The complete PANTA removal set includes instruments to be used for the removal of all PANTA nail system.
NEWDEAL
REPANTASET
Not in Commercial Distribution

  • 10381780125891 ()
  • M248REPANTASET1 ()
REPANTASET

  • General internal orthopaedic fixation system implantation kit
The Large QWIX positioning and fixation screws were designed for extremity fixation, to provide speed and precision for challenging surgical situations. The QWIX screw is a cannulated, fully threaded screw with a self-tapping screw tip. Instruments are also provided.
NEWDEAL
QWX57INSTSET
Not in Commercial Distribution

  • 10381780064459 ()
  • M248QWX57INSTSET1 ()
QWX57INSTSET

  • General internal orthopaedic fixation system implantation kit
Instrument: Drill for 3.0mm Screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-1000T-DR30
In Commercial Distribution

  • 00810005662581 ()


  • General internal orthopaedic fixation system implantation kit
Instrument: Drill for 2.4mm Screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-1000T-DR24
In Commercial Distribution

  • 00810005662574 ()


  • General internal orthopaedic fixation system implantation kit
Compression forceps, percutaneous
Ulrich GmbH & Co. KG
CS 3843-21
In Commercial Distribution

  • 04052536163243 ()
CS 3843-21

  • General internal orthopaedic fixation system implantation kit
Distraction forceps, percutaneous
Ulrich GmbH & Co. KG
CS 3843-20
In Commercial Distribution

  • 04052536163236 ()
CS 3843-20

  • General internal orthopaedic fixation system implantation kit
Screwdriver with SR 20 coupling H
Ulrich GmbH & Co. KG
CS 3848
In Commercial Distribution

  • 04052536081646 ()
CS 3848

  • General internal orthopaedic fixation system implantation kit
Rod pusher with spring, percutaneous
Ulrich GmbH & Co. KG
CS 3829
In Commercial Distribution

  • 04052536081257 ()
CS 3829

  • General internal orthopaedic fixation system implantation kit
Screwdriver, percutaneous, cannulated, hex 3.5 mm coupling A
Ulrich GmbH & Co. KG
CS 3826
In Commercial Distribution

  • 04052536081233 ()
CS 3826

  • General internal orthopaedic fixation system implantation kit
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