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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 Type Device Class Implantable

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SeaSpine Bi-Ostetic Cancellous Blocks is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. SeaSpine Bi-Ostetic Cancellous Blocks is safe and has excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. SeaSpine Bi-Ostetic Cancellous Blocks is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission. SeaSpine Bi-Ostetic Cancellous Blocks is an osteoconductive bone substitute shaped as blocks that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The blocks may be pressed into the void or into the surgical site by hand. The SeaSpine Bi-Ostetic Cancellous Blocks provide void filling material that acts as a temporary support medium. The blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. SeaSpine Bi-Ostetic Cancellous Blocks is biocompatible and resorbs in the body as bone ingrowth occurs.
BERKELEY ADVANCED BIOMATERIALS, LLC
SBiO-XYZ400606P
In Commercial Distribution

  • 00858418003966 ()
SBiO-XYZ400606P

  • Bone matrix implant, synthetic, non-antimicrobial
Newport 4.75 X 50mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4750
In Commercial Distribution

  • 10889981138813 ()

  • 4.75 X 50mm
61-4750

  • Bone-screw internal spinal fixation system, non-sterile
Newport 4.75 X 45mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4745
In Commercial Distribution

  • 10889981138806 ()

  • 4.75 X 45mm
61-4745

  • Bone-screw internal spinal fixation system, non-sterile
Newport 4.75 X 40mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4740
In Commercial Distribution

  • 10889981138790 ()

  • 4.75 X 40mm
61-4740

  • Bone-screw internal spinal fixation system, non-sterile
Newport 4.75 X 35mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4735
In Commercial Distribution

  • 10889981138783 ()

  • 4.75 X 35mm
61-4735

  • Bone-screw internal spinal fixation system, non-sterile
Newport 4.75 X 30mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4730
In Commercial Distribution

  • 10889981138776 ()

  • 4.75 X 30mm
61-4730

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.5 x 40mm
Seaspine, Inc.
63-6540
Not in Commercial Distribution

  • M5566365401 ()
  • 10381780004585 ()

  • Ø6.5 x 40mm
63-6540

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.5 x 35mm
Seaspine, Inc.
63-6535
Not in Commercial Distribution

  • M5566365351 ()
  • 10381780004578 ()

  • Ø6.5 x 35mm
63-6535

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.5 x 30mm
Seaspine, Inc.
63-6530
Not in Commercial Distribution

  • M5566365301 ()
  • 10381780004561 ()

  • Ø6.5 x 30mm
63-6530

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.5 x 25mm
Seaspine, Inc.
63-6525
Not in Commercial Distribution

  • M5566365251 ()
  • 10381780004554 ()

  • Ø6.5 x 25mm
63-6525

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.5 x 110mm
Seaspine, Inc.
63-6510
Not in Commercial Distribution

  • M5566365101 ()
  • 10381780004547 ()

  • Ø6.5 x 110mm
63-6510

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.5 x 105mm
Seaspine, Inc.
63-6505
Not in Commercial Distribution

  • M5566365051 ()
  • 10381780004530 ()

  • Ø6.5 x 105mm
63-6505

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.5 x 100mm
Seaspine, Inc.
63-6500
Not in Commercial Distribution

  • M5566365001 ()
  • 10381780004523 ()

  • Ø6.5 x 100mm
63-6500

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.0 x 60mm
Seaspine, Inc.
63-6060
Not in Commercial Distribution

  • M5566360601 ()
  • 10381780004516 ()

  • Ø6.0 x 60mm
63-6060

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.0 x 55mm
Seaspine, Inc.
63-6055
Not in Commercial Distribution

  • M5566360551 ()
  • 10381780004509 ()

  • Ø6.0 x 55mm
63-6055

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.0 x 50mm
Seaspine, Inc.
63-6050
Not in Commercial Distribution

  • M5566360501 ()
  • 10381780004493 ()

  • Ø6.0 x 50mm
63-6050

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.0 x 45mm
Seaspine, Inc.
63-6045
Not in Commercial Distribution

  • M5566360451 ()
  • 10381780004486 ()

  • Ø6.0 x 45mm
63-6045

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.0 x 40mm
Seaspine, Inc.
63-6040
Not in Commercial Distribution

  • M5566360401 ()
  • 10381780004479 ()

  • Ø6.0 x 40mm
63-6040

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.0 x 35mm
Seaspine, Inc.
63-6035
Not in Commercial Distribution

  • M5566360351 ()
  • 10381780004462 ()

  • Ø6.0 x 35mm
63-6035

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.0 x 30mm
Seaspine, Inc.
63-6030
Not in Commercial Distribution

  • M5566360301 ()
  • 10381780004455 ()

  • Ø6.0 x 30mm
63-6030

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