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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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Rebar® - M681SCC0020050

5mm Non-Lordotic Spacer
ATLAS SPINE, INC.
SCC-002-005
In Commercial Distribution

  • M681SCC0020050 ()

  • Height: 5 Millimeter
SCC-002-005

  • Polymeric spinal interbody fusion cage

Rebar® - M681SCC0010050

5mm Lordotic Spacer
ATLAS SPINE, INC.
SCC-001-005
In Commercial Distribution

  • M681SCC0010050 ()

  • Height: 5 Millimeter
SCC-001-005

  • Polymeric spinal interbody fusion cage

Apelo® / Apelo® MIS - M68111100900050

5mm MIS Extended Head
ATLAS SPINE, INC.
1110-09-0005
In Commercial Distribution

  • M68111100900050 ()

  • Length: 5 Millimeter
1110-09-0005

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

ENDOSKELETON TCS - M682521010240

NO 8 HEXALOBE, U-JOINT DRIVER
TITAN SPINE, LLC
5210-1024
Not in Commercial Distribution

  • M682521010240 ()

  • Length: 5 Inch
5210-1024

  • Orthopaedic inorganic implant inserter/extractor, reusable

ENDOSKELETON TCS - M682521010050

NO 8 HEXALOBE, SWIVEL DRIVER
TITAN SPINE, LLC
5210-1005
Not in Commercial Distribution

  • M682521010050 ()

  • Length: 5 Inch
5210-1005

  • Orthopaedic inorganic implant inserter/extractor, reusable

ENDOSKELETON TCS - M682521010040

NO 8 HEXALOBE, STRAIGHT DRIVER
TITAN SPINE, LLC
5210-1004
Not in Commercial Distribution

  • M682521010040 ()

  • Length: 5 Inch
5210-1004

  • Orthopaedic inorganic implant inserter/extractor, reusable

ENDOSKELETON TCS - M682521010480

BONE SCREW EXTRACTOR
TITAN SPINE, LLC
5210-1048
Not in Commercial Distribution

  • M682521010480 ()

  • Length: 5 Inch
5210-1048

  • Orthopaedic inorganic implant inserter/extractor, reusable

AXIOM® - M68414147505001

AXIOM® MODULAR FEMORAL AUGMENT 75mm X 5mm DISTAL
Microport Orthopedics Inc.
1414750500
In Commercial Distribution

  • 1414750500 ()
  • M68414147505001 ()

  • Height: 5 Millimeter
1414750500

  • Knee arthroplasty wedge

AXIOM® - M68414147005001

AXIOM® MODULAR FEMORAL AUGMENT 70mm X 5mm DISTAL
Microport Orthopedics Inc.
1414700500
In Commercial Distribution

  • 1414700500 ()
  • M68414147005001 ()

  • Height: 5 Millimeter
1414700500

  • Knee arthroplasty wedge

AXIOM® - M68414146505001

AXIOM® MODULAR FEMORAL AUGMENT 65mm X 5mm DISTAL
Microport Orthopedics Inc.
1414650500
In Commercial Distribution

  • 1414650500 ()
  • M68414146505001 ()

  • Height: 5 Millimeter
1414650500

  • Knee arthroplasty wedge
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