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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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Dual Core Cortical Locking Screw - B058HTNU4601

Dual Core Cortical Locking Screw - Ø4mm x 60mm
Orthopedic Designs North America, Inc.
HTNU460
In Commercial Distribution

  • B058HTNU4601 ()

  • Outer Diameter: 4 Millimeter
  • Length: 60 Millimeter
HTN-U-4-60

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

ODI 7.0mm Cannulated Screw System - B058CSS7020601

ODI 7.0mm Cannulated Screw – 7.0mm x 60mm
Orthopedic Designs North America, Inc.
CSS702060
In Commercial Distribution

  • B058CSS7020601 ()

  • Length: 60 Millimeter
  • Outer Diameter: 7 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Talon™ DistalFix™ ART Cortical Screw - B058ART5060NS1

Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 060mm (non-sterile)
Orthopedic Designs North America, Inc.
ART5060NS
In Commercial Distribution

  • B058ART5060NS1 ()

  • Outer Diameter: 5 Millimeter
  • Length: 60 Millimeter
ART-5-060NS

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Talon™ DistalFix™ ART Cortical Screw - B058ART50601

Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 060mm
Orthopedic Designs North America, Inc.
ART5060
In Commercial Distribution

  • B058ART50601 ()

  • Outer Diameter: 5 Millimeter
  • Length: 60 Millimeter
ART-5-060

  • Orthopaedic bone screw, non-bioabsorbable, sterile

ORTHROS - B030CP009550

Ø5.5mm Anti-Rotation Curved Rod , 60 mm Lg.
CAMBER SPINE TECHNOLOGIES, LLC
CP-009-55
In Commercial Distribution

  • B030CP009550 ()

  • Length: 60 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Polymeric spinal interbody fusion cage

ORTHROS - B030CP008460

Ø5.5mm Anti-Rotation Straight Rod , 60 mm Lg.
CAMBER SPINE TECHNOLOGIES, LLC
CP-008-46
In Commercial Distribution

  • B030CP008460 ()

  • Length: 60 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Polymeric spinal interbody fusion cage

Siconus™ SI Joint Fixation System - B030SCL070600

Ø7mm Bone Screw, Cannulated, 60mm
CAMBER SPINE TECHNOLOGIES, LLC
SCL-07-060
In Commercial Distribution

  • B030SCL070600 ()

  • Outer Diameter: 7 Millimeter
  • Length: 60 Millimeter


  • Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile

Orthros - B030ORT8560CR0

Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 60mm Lg.
CAMBER SPINE TECHNOLOGIES, LLC
ORT-8560CR
In Commercial Distribution

  • B030ORT8560CR0 ()

  • Length: 60 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Orthros - B030ORT7560CR0

Ø7.5mm Cannulated Polyaxial Reduction Pedicle Screw, 60mm Lg.
CAMBER SPINE TECHNOLOGIES, LLC
ORT-7560CR
In Commercial Distribution

  • B030ORT7560CR0 ()

  • Length: 60 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Orthros - B030ORT65600

Ø6.5mm Polyaxial Pedicle Screw, 60mm Lg.
CAMBER SPINE TECHNOLOGIES, LLC
ORT-6560
In Commercial Distribution

  • B030ORT65600 ()

  • Length: 60 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
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