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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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Threaded Driver
FLOSPINE LLC
Panama™
In Commercial Distribution

  • B1830870000010 ()
08-7000-001

  • Surgical screwdriver, reusable
Integra® Freedom Wrist Arthroplasty System 2.5mm Hex Driver
Ascension Orthopedics, Inc.
348101
In Commercial Distribution

  • M2483481011 ()
  • 10381780278382 ()
348101

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Integra® Freedom Wrist Arthroplasty System T15 Star Driver
Ascension Orthopedics, Inc.
348095
In Commercial Distribution

  • M2483480951 ()
  • 10381780278375 ()

  • 100mm Length x 4.50mm Diameter
348095

  • Surgical screwdriver, reusable
Integra® Freedom Wrist Arthroplasty System 4.0mm Stop Drill Bit
Ascension Orthopedics, Inc.
348094
In Commercial Distribution

  • M2483480941 ()
  • 10381780278368 ()

  • 100mm Length x 4.50mm Diameter
348094

  • Surgical screwdriver, reusable
Screwdriver (For All Dermatomes)
INTEGRA LIFESCIENCES CORPORATION
3539257
In Commercial Distribution

  • M24835392571 ()
  • 10381780277415 ()
3539257

  • Surgical screwdriver, reusable
3 1/2" Screwdriver Bit, Star, T4 Small Quick Coupling
Surgical Direct, Inc.
SD144930-2050
In Commercial Distribution

  • B382SD4493020500 ()
SD144930-2050

  • Surgical screwdriver, reusable
The Integra External Fixation System set consists of rings, footplates, anterior cross bars, and a rockerbottom. These devices are used for stability and structure. The external fixation device is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
Ascension Orthopedics, Inc.
XFIX4RCKRIMP
Not in Commercial Distribution

  • M268XFIX4RCKRIMP1 ()
  • 10381780125723 ()
XFIX4RCKRIMP

  • External orthopaedic fixation system, reusable
The Integra External Fixation System set consists of wires, half-pins, nuts, and bolts. Instruments are also included to aid in assembly. The external fixation device is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
Ascension Orthopedics, Inc.
XFIX1BOLTIMP
Not in Commercial Distribution

  • M268XFIX1BOLTIMP1 ()
  • 10381780125709 ()
XFIX1BOLTIMP

  • External orthopaedic fixation system, reusable
The Integra External Fixation System set consists of rings and footplates. These devices are used for stability and structure. The external fixation device is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
Ascension Orthopedics, Inc.
XFIX5RINGIMP
Not in Commercial Distribution

  • M268XFIX5RINGIMP1 ()
  • 10381780125730 ()
XFIX5RINGIMP

  • External orthopaedic fixation system, reusable
The Integra External Fixation System set consists of struts, rods, and hex posts. These devices are used for support in the construct. Plates and a universal joint are also included. The external fixation device is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
Ascension Orthopedics, Inc.
XFIX2RODSIMP
Not in Commercial Distribution

  • M268XFIX2RODSIMP1 ()
  • 10381780125716 ()
XFIX2RODSIMP

  • External orthopaedic fixation system, reusable
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