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 Class Implantable

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Polyaxial Screw 8.5mm Diameter 45mm length
CALVARY SPINE, LLC
18545
In Commercial Distribution

  • B115185450 ()
18545

  • Spinal bone screw, non-bioabsorbable
Polyaxial Screw 8.5mm Diameter 40mm length
CALVARY SPINE, LLC
18540
In Commercial Distribution

  • B11485400 ()
18540

  • Spinal bone screw, non-bioabsorbable
Illiac Connector 5.5mm Diameter 50mm Rod Length
CALVARY SPINE, LLC
850
In Commercial Distribution

  • B1148500 ()
850

  • Bone-screw internal spinal fixation system connector
Illiac Connector 5.5mm Diameter 30mm Rod Length
CALVARY SPINE, LLC
830
In Commercial Distribution

  • B1148300 ()
830

  • Bone-screw internal spinal fixation system connector
Polyaxial Screw 7.5mm Diameter 55mm length
CALVARY SPINE, LLC
17555
In Commercial Distribution

  • B11475550 ()
17555

  • Spinal bone screw, non-bioabsorbable
Polyaxial Screw 7.5mm Diameter 30mm length
CALVARY SPINE, LLC
17530
In Commercial Distribution

  • B11475300 ()
17530

  • Spinal bone screw, non-bioabsorbable
PreLordosed Rod 5.5mm Diameter 80mm length Ti6Al4V
CALVARY SPINE, LLC
580
In Commercial Distribution

  • B1145800 ()
580

  • Bone-screw internal spinal fixation system rod
PreLordosed Rod 5.5mm Diameter 60mm length Ti6Al4V
CALVARY SPINE, LLC
560
In Commercial Distribution

  • B1145600 ()
560

  • Bone-screw internal spinal fixation system rod
Straight Rod 5.5mm Diameter 480mm length Ti6Al4V
CALVARY SPINE, LLC
5480
In Commercial Distribution

  • B11454800 ()
5480

  • Bone-screw internal spinal fixation system rod
PreLordosed Rod 5.5mm Diameter 40mm length Ti6Al4V
CALVARY SPINE, LLC
540
In Commercial Distribution

  • B1145400 ()
540

  • Bone-screw internal spinal fixation system rod
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