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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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Preference 2 - M555207204060

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø7.2 x 60mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555207204060 ()

  • Length: 60 Millimeter
  • Outer Diameter: 7.2 Millimeter
20-7204-060

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555207204055

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø7.2 x 55mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555207204055 ()

  • Outer Diameter: 7.2 Millimeter
  • Length: 55 Millimeter
20-7204-055

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555207204050

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø7.2 x 50mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555207204050 ()

  • Length: 50 Millimeter
  • Outer Diameter: 7.2 Millimeter
20-7204-050

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555207204045

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø7.2 x 45mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555207204045 ()

  • Outer Diameter: 7.2 Millimeter
  • Length: 45 Millimeter
20-7204-045

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555207204040

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø7.2 x 40mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555207204040 ()

  • Length: 40 Millimeter
  • Outer Diameter: 7.2 Millimeter
20-7204-040

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555207204035

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø7.2 x 35mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555207204035 ()

  • Outer Diameter: 7.2 Millimeter
  • Length: 35 Millimeter
20-7204-035

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555207204030

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø7.2 x 30mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555207204030 ()

  • Length: 30 Millimeter
  • Outer Diameter: 7.2 Millimeter
20-7204-030

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555205504055

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø5.5 x 55mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555205504055 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 55 Millimeter
20-5504-055

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555205504050

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø5.5 x 50mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555205504050 ()

  • Length: 50 Millimeter
  • Outer Diameter: 5.5 Millimeter
20-5504-050

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555205504045

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø5.5 x 45mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555205504045 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 45 Millimeter
20-5504-045

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555205504040

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø5.5 x 40mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555205504040 ()

  • Length: 40 Millimeter
  • Outer Diameter: 5.5 Millimeter
20-5504-040

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555205504035

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø5.5 x 35mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555205504035 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 35 Millimeter
20-5504-035

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555205504030

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø5.5 x 30mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555205504030 ()

  • Length: 30 Millimeter
  • Outer Diameter: 5.5 Millimeter
20-5504-030

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555205504025

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø5.5 x 25mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555205504025 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 25 Millimeter
20-5504-025

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555206504060

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø6.5 x 60mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555206504060 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 60 Millimeter
20-6504-060

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555206504055

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø6.5 x 55mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555206504055 ()

  • Length: 55 Millimeter
  • Outer Diameter: 6.5 Millimeter
20-6504-055

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555206504050

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø6.5 x 50mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555206504050 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 50 Millimeter
20-6504-050

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555206504045

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø6.5 x 45mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555206504045 ()

  • Length: 45 Millimeter
  • Outer Diameter: 6.5 Millimeter
20-6504-045

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555206504040

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø6.5 x 40mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555206504040 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 40 Millimeter
20-6504-040

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555206504035

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø6.5 x 35mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555206504035 ()

  • Length: 35 Millimeter
  • Outer Diameter: 6.5 Millimeter
20-6504-035

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555206504030

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø6.5 x 30mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555206504030 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 30 Millimeter
20-6504-030

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555206504025

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø6.5 x 25mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555206504025 ()

  • Length: 25 Millimeter
  • Outer Diameter: 6.5 Millimeter
20-6504-025

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555204504045

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø4.5 x 45mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555204504045 ()

  • Length: 45 Millimeter
  • Outer Diameter: 4.5 Millimeter
20-4504-045

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555204504040

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø4.5 x 40mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555204504040 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 40 Millimeter
20-4504-040

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555204504035

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø4.5 x 35mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555204504035 ()

  • Length: 35 Millimeter
  • Outer Diameter: 4.5 Millimeter
20-4504-035

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555204504030

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø4.5 x 30mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555204504030 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 30 Millimeter
20-4504-030

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555204504025

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø4.5 x 25mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555204504025 ()

  • Length: 25 Millimeter
  • Outer Diameter: 4.5 Millimeter
20-4504-025

  • Spinal bone screw, non-bioabsorbable

AccuPlan System - 00864582000298

ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES, SINGLE JAW
Medcad
MC-KTP010-H
In Commercial Distribution

  • 00864582000298 ()
MC-KTP010-H

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized

AccuPlan System - 00864582000281

ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM GUIDES, SINGLE JAW
Medcad
MC-KTP010
In Commercial Distribution

  • 00864582000281 ()
MC-KTP010

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory

AccuPlan System - 00864582000274

ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES
Medcad
MC-KTP000-H
In Commercial Distribution

  • 00864582000274 ()
MC-KTP000-H

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized

AccuPlan/AccuPlate - 00810007631318

MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE
Medcad
ZB-KP200
Not in Commercial Distribution

  • 00810007631318 ()
ZB-KP200

  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory
  • Craniofacial fixation plate, non-bioabsorbable, non-customized

AccuPlan/AccuPlate - 00810007631301

MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE, NO GUIDES
Medcad
ZB-KP210
Not in Commercial Distribution

  • 00810007631301 ()
ZB-KP210

  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory
  • Craniofacial fixation plate, non-bioabsorbable, non-customized

AccuPlan/AccuPlate - 00810007631172

MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE, NO GUIDES
Medcad
ZB-KP110
Not in Commercial Distribution

  • 00810007631172 ()
ZB-KP110

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit

AccuPlan/AccuPlate - 00810007631165

MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE
Medcad
ZB-KP100
Not in Commercial Distribution

  • 00810007631165 ()
ZB-KP100

  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory
  • Craniofacial fixation plate, non-bioabsorbable, non-customized

AccuPlan System - 00810007633237

MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE 3DTI BUNDLE
Medcad
ZB-KP230
In Commercial Distribution

  • 00810007633237 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory

AccuPlan System - 00810007633220

MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE 3DTI BUNDLE
Medcad
ZB-KP130
In Commercial Distribution

  • 00810007633220 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory

AccuPlan System - 00810007633213

MIDFACE RECONSTURCTION, SURGICAL PLANNING KIT W/ ACCUPLATE 3DTI AND TITANIUM HYBRID GUIDES BUNDLE
Medcad
ZB-KTP230-H
In Commercial Distribution

  • 00810007633213 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory

AccuPlan System - 00810007633206

MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT W/ ACCUPLATE 3DTI AND TITANIUM GUIDES BUNDLE
Medcad
ZB-KTP230
In Commercial Distribution

  • 00810007633206 ()


  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized

AccuPlan System - 00810007633190

MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE 3DTI AND TITANIUM HYBRID GUIDES BUNDLE
Medcad
ZB-KTP130-H
In Commercial Distribution

  • 00810007633190 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory

AccuPlan System - 00810007633183

MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT W/ ACCUPLATE 3DTI AND TITANIUM GUIDES BUNDLE
Medcad
ZB-KTP130
In Commercial Distribution

  • 00810007633183 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory

AccuPlan System - 00810007632926

MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE 3DTI BUNDLE
Medcad
MC-KP230
In Commercial Distribution

  • 00810007632926 ()


  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized

AccuPlan System - 00810007632919

MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE 3DTI BUNDLE
Medcad
MC-KP130
In Commercial Distribution

  • 00810007632919 ()


  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized

AccuPlan System - 00810007632902

MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT W/ ACCUPLATE 3DTI AND TITANIUM HYBRID GUIDES BUNDLE
Medcad
MC-KTP230-H
In Commercial Distribution

  • 00810007632902 ()


  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized

AccuPlan System - 00810007632896

MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT W/ ACCUPLATE 3DTI AND TITANIUM GUIDES BUNDLE
Medcad
MC-KTP230
In Commercial Distribution

  • 00810007632896 ()


  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized

AccuPlan System - 00810007632889

MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE 3DTI AND TITANIUM HYBRID GUIDES BUNDLE
Medcad
MC-KTP130-H
In Commercial Distribution

  • 00810007632889 ()


  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized

AccuPlan System - 00810007632872

MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT W/ ACCUPLATE 3DTI AND TITANIUM GUIDES BUNDLE
Medcad
MC-KTP130
In Commercial Distribution

  • 00810007632872 ()


  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized

AccuPlan System - 00810007632452

MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES BUNDLE
Medcad
ZB-KP400
In Commercial Distribution

  • 00810007632452 ()
ZB-KP400

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized

AccuPlan System - 00810007632445

MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES BUNDLE
Medcad
ZB-KP300
In Commercial Distribution

  • 00810007632445 ()
ZB-KP300

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized

AccuPlan System - 00810007632438

MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES BUNDLE
Medcad
ZB-KTP400-H
In Commercial Distribution

  • 00810007632438 ()
ZB-KTP400-H

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized

AccuPlan System - 00810007632421

MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM GUIDES BUNDLE
Medcad
ZB-KTP400
In Commercial Distribution

  • 00810007632421 ()
ZB-KTP400

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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