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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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APEX Spine System - M8246000450D1

Titanium Rod 6.0 x 450mm, Deformity
SPINECRAFT, LLC
6000-450D
In Commercial Distribution

  • M8246000450D1 ()


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

APEX Spine System - M82460004501

Titanium Rod 6.0 x 450mm, Straight
SPINECRAFT, LLC
6000-450
In Commercial Distribution

  • M82460004501 ()


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

APEX Spine System - M8246000325D1

Ti Straight Rod 6X325mm, Deformity
SPINECRAFT, LLC
6000-325D
In Commercial Distribution

  • M8246000325D1 ()
6000-325D

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

APEX Spine System - M82460003251

Ti Straight Rod 6X325mm
SPINECRAFT, LLC
6000-325
In Commercial Distribution

  • M82460003251 ()
6000-325

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

APEX Spine System - M8246000300D1

Titanium Rod 6.0 x 300mm, Deformity
SPINECRAFT, LLC
6000-300D
In Commercial Distribution

  • M8246000300D1 ()


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

APEX Spine System - M82460003001

Titanium Rod 6.0 x 300mm, Straight
SPINECRAFT, LLC
6000-300
In Commercial Distribution

  • M82460003001 ()


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

APEX-DL Spine System - M8246000130ML1

Ti MIS Rod 6.0 x 130mm, Lordosed
SPINECRAFT, LLC
6000-130ML
In Commercial Distribution

  • M8246000130ML1 ()


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

APEX-DL Spine System - M8246000120ML1

Ti MIS Rod 6.0 x 120mm, Lordosed
SPINECRAFT, LLC
6000-120ML
In Commercial Distribution

  • M8246000120ML1 ()


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

APEX-DL Spine System - M8246000110ML1

Ti MIS Rod 6.0 x 110mm, Lordosed
SPINECRAFT, LLC
6000-110ML
In Commercial Distribution

  • M8246000110ML1 ()


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

APEX-DL Spine System - M8246000100ML1

Ti MIS Rod 6.0 x 100mm, Lordosed
SPINECRAFT, LLC
6000-100ML
In Commercial Distribution

  • M8246000100ML1 ()


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

APEX Spine System - M8246000100L1

Titanium Rod 6.0 x 100mm, Lordosed
SPINECRAFT, LLC
6000-100L
In Commercial Distribution

  • M8246000100L1 ()


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

APEX-DL Spine System - M8246000090ML1

Ti MIS Rod 6.0 x 90mm, Lordosed
SPINECRAFT, LLC
6000-090ML
In Commercial Distribution

  • M8246000090ML1 ()


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

APEX Spine System - M8246000090L1

Titanium Rod 6.0 x 90mm, Lordosed
SPINECRAFT, LLC
6000-090L
In Commercial Distribution

  • M8246000090L1 ()


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

APEX Spine System - M82460000901

Titanium Rod 6.0 x 90mm, Straight
SPINECRAFT, LLC
6000-090
In Commercial Distribution

  • M82460000901 ()


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

ASTRA Spine System - M824A5P7540C1

ASTRA Ti Cannulated Polyaxial Screw 7.50 x 40mm
SPINECRAFT, LLC
A5P-7540-C
In Commercial Distribution

  • M824A5P7540C1 ()


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

ASTRA Spine System - M824A5P75401

ASTRA Ti Polyaxial Screw 7.50 x 40mm
SPINECRAFT, LLC
A5P-7540
In Commercial Distribution

  • M824A5P75401 ()


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

ASTRA Spine System - M824A5P7535RC1

ASTRA Ti Cannulated Polyaxial Reduction Screw 7.50 x 35mm
SPINECRAFT, LLC
A5P-7535R-C
In Commercial Distribution

  • M824A5P7535RC1 ()


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

ASTRA Spine System - M824A5P7535EC1

ASTRA Ti Cannulated Polyaxial Extended Screw 7.50 x 35mm
SPINECRAFT, LLC
A5P-7535E-C
In Commercial Distribution

  • M824A5P7535EC1 ()


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

ASTRA Spine System - M824A5P75351

ASTRA Ti Polyaxial Screw 7.50 x 35mm
SPINECRAFT, LLC
A5P-7535
In Commercial Distribution

  • M824A5P75351 ()


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

ASTRA Spine System - M824A5P7530RC1

ASTRA Ti Cannulated Polyaxial Reduction Screw 7.50 x 30mm
SPINECRAFT, LLC
A5P-7530R-C
In Commercial Distribution

  • M824A5P7530RC1 ()


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

ASTRA Spine System - M824A5P7530EC1

ASTRA Ti Cannulated Polyaxial Extended Screw 7.50 x 30mm
SPINECRAFT, LLC
A5P-7530E-C
In Commercial Distribution

  • M824A5P7530EC1 ()


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

ASTRA Spine System - M824A5P7525C1

ASTRA Ti Cannulated Polyaxial Screw 7.50 x 25mm
SPINECRAFT, LLC
A5P-7525-C
In Commercial Distribution

  • M824A5P7525C1 ()


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

ASTRA Spine System - M824A5P75251

ASTRA Ti Polyaxial Screw 7.50 x 25mm
SPINECRAFT, LLC
A5P-7525
In Commercial Distribution

  • M824A5P75251 ()


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

ASTRA Spine System - M824A5P75100RC1

ASTRA Ti Cannulated Polyaxial Reduction Screw 7.50 x 100mm
SPINECRAFT, LLC
A5P-75100R-C
In Commercial Distribution

  • M824A5P75100RC1 ()


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

ASTRA Spine System - M824A5P751001

ASTRA Ti Polyaxial Screw 7.50 x 100mm
SPINECRAFT, LLC
A5P-75100
In Commercial Distribution

  • M824A5P751001 ()


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

ASTRA Spine System - M824A5P7090C1

ASTRA Ti Cannulated Polyaxial Screw 7.00 x 90mm
SPINECRAFT, LLC
A5P-7090-C
In Commercial Distribution

  • M824A5P7090C1 ()


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

ASTRA Spine System - M824A5P70901

ASTRA Ti Polyaxial Screw 7.00 x 90mm
SPINECRAFT, LLC
A5P-7090
In Commercial Distribution

  • M824A5P70901 ()


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

ASTRA Spine System - M824A5P7080R1

ASTRA Ti Polyaxial Reduction Screw 7.00 x 80mm
SPINECRAFT, LLC
A5P-7080R
In Commercial Distribution

  • M824A5P7080R1 ()


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

ASTRA Spine System - M824A5P7070RC1

ASTRA Ti Cannulated Polyaxial Reduction Screw 7.00 x 70mm
SPINECRAFT, LLC
A5P-7070R-C
In Commercial Distribution

  • M824A5P7070RC1 ()


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

ASTRA Spine System - M824A5P7070C1

ASTRA Ti Cannulated Polyaxial Screw 7.00 x 70mm
SPINECRAFT, LLC
A5P-7070-C
In Commercial Distribution

  • M824A5P7070C1 ()


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

ASTRA Spine System - M824A5P70701

ASTRA Ti Polyaxial Screw 7.00 x 70mm
SPINECRAFT, LLC
A5P-7070
In Commercial Distribution

  • M824A5P70701 ()


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

ASTRA Spine System - M824A5P7045R1

ASTRA Ti Polyaxial Reduction Screw 7.00 x 45mm
SPINECRAFT, LLC
A5P-7045R
In Commercial Distribution

  • M824A5P7045R1 ()


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

ASTRA Spine System - M824A5P7045C1

ASTRA Ti Cannulated Polyaxial Screw 7.00 x 45mm
SPINECRAFT, LLC
A5P-7045-C
In Commercial Distribution

  • M824A5P7045C1 ()


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

ASTRA Spine System - M824A5P7040RC1

ASTRA Ti Cannulated Polyaxial Reduction Screw 7.00 x 40mm
SPINECRAFT, LLC
A5P-7040R-C
In Commercial Distribution

  • M824A5P7040RC1 ()


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

ASTRA Spine System - M824A5P7040C1

ASTRA Ti Cannulated Polyaxial Screw 7.00 x 40mm
SPINECRAFT, LLC
A5P-7040-C
In Commercial Distribution

  • M824A5P7040C1 ()


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

ASTRA Spine System - M824A5P7035R1

ASTRA Ti Polyaxial Reduction Screw 7.00 x 35mm
SPINECRAFT, LLC
A5P-7035R
In Commercial Distribution

  • M824A5P7035R1 ()


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

ASTRA Spine System - M824A5P7035C1

ASTRA Ti Cannulated Polyaxial Screw 7.00 x 35mm
SPINECRAFT, LLC
A5P-7035-C
In Commercial Distribution

  • M824A5P7035C1 ()


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

ASTRA Spine System - M824A5P70351

ASTRA Ti Polyaxial Screw 7.00 x 35mm
SPINECRAFT, LLC
A5P-7035
In Commercial Distribution

  • M824A5P70351 ()


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

ASTRA Spine System - M824A5P7030RC1

ASTRA Ti Cannulated Polyaxial Reduction Screw 7.00 x 30mm
SPINECRAFT, LLC
A5P-7030R-C
In Commercial Distribution

  • M824A5P7030RC1 ()


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

ASTRA Spine System - M824A5P7030C1

ASTRA Ti Cannulated Polyaxial Screw 7.00 x 30mm
SPINECRAFT, LLC
A5P-7030-C
In Commercial Distribution

  • M824A5P7030C1 ()


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

ASTRA Spine System - M824A5P7025RC1

ASTRA Ti Cannulated Polyaxial Reduction Screw 7.00 x 25mm
SPINECRAFT, LLC
A5P-7025R-C
In Commercial Distribution

  • M824A5P7025RC1 ()


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

ASTRA Spine System - M824A5P7025C1

ASTRA Ti Cannulated Polyaxial Screw 7.00 x 25mm
SPINECRAFT, LLC
A5P-7025-C
In Commercial Distribution

  • M824A5P7025C1 ()


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

ASTRA Spine System - M824A5P70100C1

ASTRA Ti Cannulated Polyaxial Screw 7.00 x 100mm
SPINECRAFT, LLC
A5P-70100-C
In Commercial Distribution

  • M824A5P70100C1 ()


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

ASTRA Spine System - M824A5P701001

ASTRA Ti Polyaxial Screw 7.00 x 100mm
SPINECRAFT, LLC
A5P-70100
In Commercial Distribution

  • M824A5P701001 ()


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

ASTRA Spine System - M824A5P6580R1

ASTRA Ti Poly Reduction Screw 6.50 x 80mm
SPINECRAFT, LLC
A5P-6580R
In Commercial Distribution

  • M824A5P6580R1 ()


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

ASTRA Spine System - M824A5P6580C1

ASTRA Ti Cannulated Polyaxial Screw 6.50 x 80mm
SPINECRAFT, LLC
A5P-6580-C
In Commercial Distribution

  • M824A5P6580C1 ()


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

ASTRA Spine System - M824A5P65701

ASTRA Ti Poly Screw 6.50 x 70mm
SPINECRAFT, LLC
A5P-6570
In Commercial Distribution

  • M824A5P65701 ()


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

ASTRA Spine System - M824A5P6560RC1

ASTRA Ti Cannulated Polyaxial Reduction Screw 6.50 x 60mm
SPINECRAFT, LLC
A5P-6560R-C
In Commercial Distribution

  • M824A5P6560RC1 ()


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

ASTRA Spine System - M824A5P6560R1

ASTRA Ti Poly Reduction Screw 6.50 x 60mm
SPINECRAFT, LLC
A5P-6560R
In Commercial Distribution

  • M824A5P6560R1 ()


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

ASTRA Spine System - M824A5P6560EC1

ASTRA Ti Cannulated Polyaxial Extended Screw 6.50 x 60mm
SPINECRAFT, LLC
A5P-6560E-C
In Commercial Distribution

  • M824A5P6560EC1 ()


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