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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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Integra® External Fixation System - 10381780125723

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

Integra® External Fixation System - 10381780125716

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

Integra® External Fixation System - 10381780125709

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

Surgical Direct - B382SD9147241010

8 3/4 inch Impactor, 7mm
Surgical Direct, Inc.
SD914724101
In Commercial Distribution

  • B382SD9147241010 ()
SD914724101

  • Surgical mallet

Surgical Direct - B382SD9147211050

8 3/4” Anterior Cervical Graft Driver, Guarded, 1/4” Tip
Surgical Direct, Inc.
SD914721105
In Commercial Distribution

  • B382SD9147211050 ()
SD914721105

  • Surgical tamp, reusable

Surgical Direct - B382SD9152181040

8" Caspar Screwdriver for Distraction Pins
Surgical Direct, Inc.
SD915218104
In Commercial Distribution

  • B382SD9152181040 ()
SD915218104

  • Surgical screwdriver, reusable

GEO Staple System - B471240000020

Staple Tamp, Large
GRAMERCY EXTREMITY ORTHOPEDICS LLC
24000002
In Commercial Distribution

  • B471240000020 ()


  • Orthopaedic bone staple driver

GEO Staple System - B471240000010

Staple Tamp, Small
GRAMERCY EXTREMITY ORTHOPEDICS LLC
24000001
In Commercial Distribution

  • B471240000010 ()


  • Orthopaedic bone staple driver

GEO Bone Screw System - B471212502300

Drill Bit 5.0mmx230mm ZH Cannulated
GRAMERCY EXTREMITY ORTHOPEDICS LLC
21250230
In Commercial Distribution

  • B471212502300 ()

  • Outer Diameter: 5.0 Millimeter
  • Length: 230 Millimeter


  • Cannulated surgical drill bit, single-use

GEO Bone Screw System - B471212501600

Drill Bit 5.0mmx160mm ZH Cannulated
GRAMERCY EXTREMITY ORTHOPEDICS LLC
21250160
In Commercial Distribution

  • B471212501600 ()

  • Length: 160 Millimeter
  • Outer Diameter: 5.0 Millimeter


  • Cannulated surgical drill bit, single-use
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