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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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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
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
No Description
American Medicals
1
In Commercial Distribution

  • B35632686250 ()


  • Surgical mallet
No Description
American Medicals
1
In Commercial Distribution

  • B35618736200 ()


  • Surgical screwdriver, reusable
Symbios BoneShield rectangular 33x25 mm
Dentsply Implants Manufacturing GmbH
32597402
In Commercial Distribution

32597402

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Symbios BoneShield oval 20x15 mm
Dentsply Implants Manufacturing GmbH
32597400
In Commercial Distribution

32597400

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Snag Resistant Webster Needle Driver
Aligned Medical Solutions
DDS1156
In Commercial Distribution

  • B098DDS11561 ()
  • B098DDS11560 ()
DDS1156

  • General surgical procedure kit, non-medicated, single-use
ELEOS Extension Driver T25
ONKOS SURGICAL, INC.
TW-T2514-01N
In Commercial Distribution

  • B278TWT251401N0 ()
TW-T2514-01N

  • Orthopaedic prosthesis implantation positioning instrument, reusable
ELEOS Screw Driver Handle
ONKOS SURGICAL, INC.
SD-HAN14-01N
In Commercial Distribution

  • B278SDHAN1401N0 ()
SD-HAN14-01N

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Hammer
ONKOS SURGICAL, INC.
imham
In Commercial Distribution

IMHAM

  • Surgical mallet
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