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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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CrossRoads™ Bone Screw - 00850310006410

CrossRoads™ Bone Screw System is used for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the bone screw.
CROSSROADS EXTREMITY SYSTEMS
Snap-Off Driver - Sterile
In Commercial Distribution

  • 00850310006410 ()
1456-0026

  • Surgical screwdriver, single-use

CrossTIE™ 2.0mm Hex Driver Cannulated - 00850310006397

Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe, mallet toe and inter-digital fusions.
CROSSROADS EXTREMITY SYSTEMS
1456-0018
In Commercial Distribution

  • 00850310006397 ()
1456-0018

  • Orthopaedic inorganic implant inserter/extractor, reusable

CrossTIE™ H10 Driver Cannulated - 00850310006380

Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe, mallet toe and inter-digital fusions.
CROSSROADS EXTREMITY SYSTEMS
1456-0015
In Commercial Distribution

  • 00850310006380 ()
1456-0015

  • Orthopaedic inorganic implant inserter/extractor, reusable

Conformis Hip System - 00850268007552

3.5MM HEX U-JOINT DRIVER
Conformis, Inc.
1080-561
In Commercial Distribution

  • 00850268007552 ()

  • Outer Diameter: 3.5 Millimeter


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Conformis Hip System - 00850268007545

DRIVER, RIGID, 3.5MM HEX
Conformis, Inc.
1080-560
In Commercial Distribution

  • 00850268007545 ()

  • Outer Diameter: 3.5 Millimeter


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SI-RESTORE - 00850073363294

SCREWDRIVER
BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
1701-300035
In Commercial Distribution

  • 00850073363294 ()


  • Surgical screwdriver, reusable

SI-RESTORE - 00850073363270

MALLET
BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
1701-300031
In Commercial Distribution

  • 00850073363270 ()


  • Surgical mallet

SI-RESTORE - 00850073363218

SCREWDRIVER
BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
1701-300017
In Commercial Distribution

  • 00850073363218 ()


  • Surgical screwdriver, reusable

SAM Medical - 00850068519033

SAM IO Driver
ZIEN MEDICAL TECHNOLOGIES, INC.
IO700
In Commercial Distribution

  • 10850068519030 ()
  • 00850068519033 ()


  • Intraosseous-access handpiece, infusion, manual

Wheelhouse Medical Specials - 00850058050102

No Description
Wheelhouse Medical
WM01-0112
In Commercial Distribution

  • 00850058050102 ()


  • Surgical screwdriver, reusable
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