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
Malibu Deformity Implant
Seaspine, Inc.
MLBDFIMP
Not in Commercial Distribution

  • M556MLBDFIMP1 ()
  • 10381780031604 ()
MLBDFIMP

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.5 x 95mm
Seaspine, Inc.
61-7595
Not in Commercial Distribution

  • M5566175951 ()
  • 10381780031475 ()

  • DIA 7.5 x 95mm
61-7595

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.5 x 90mm
Seaspine, Inc.
61-7590
Not in Commercial Distribution

  • M5566175901 ()
  • 10381780031468 ()

  • DIA 7.5 x 90mm
61-7590

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.5 x 80mm
Seaspine, Inc.
61-7580
Not in Commercial Distribution

  • M5566175801 ()
  • 10381780031444 ()

  • DIA 7.5 x 80mm
61-7580

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.5 x 75mm
Seaspine, Inc.
61-7575
Not in Commercial Distribution

  • M5566175751 ()
  • 10381780031437 ()

  • DIA 7.5 x 75mm
61-7575

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.5 x 70mm
Seaspine, Inc.
61-7570
Not in Commercial Distribution

  • M5566175701 ()
  • 10381780031420 ()

  • DIA 7.5 x 70mm
61-7570

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.5 x 65mm
Seaspine, Inc.
61-7565
Not in Commercial Distribution

  • M5566175651 ()
  • 10381780031413 ()

  • DIA 7.5 x 65mm
61-7565

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.5 x 55mm
Seaspine, Inc.
61-7555
Not in Commercial Distribution

  • M5566175551 ()
  • 10381780031390 ()

  • DIA 7.5 x 55mm
61-7555

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.5 x 50mm
Seaspine, Inc.
61-7550
Not in Commercial Distribution

  • M5566175501 ()
  • 10381780031383 ()

  • DIA 7.5 x 50mm
61-7550

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.5 x 45mm
Seaspine, Inc.
61-7545
Not in Commercial Distribution

  • M5566175451 ()
  • 10381780031376 ()

  • DIA 7.5 x 45mm
61-7545

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.5 x 35mm
Seaspine, Inc.
61-7535
Not in Commercial Distribution

  • M5566175351 ()
  • 10381780031352 ()

  • DIA 7.5 x 35mm
61-7535

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.5 x 110mm
Seaspine, Inc.
61-7510
Not in Commercial Distribution

  • M5566175101 ()
  • 10381780031338 ()

  • DIA 7.5 x 110mm
61-7510

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.5 x 105mm
Seaspine, Inc.
61-7505
Not in Commercial Distribution

  • M5566175051 ()
  • 10381780031321 ()

  • DIA 7.5 x 105mm
61-7505

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.5 x 100mm
Seaspine, Inc.
61-7500
Not in Commercial Distribution

  • M5566175001 ()
  • 10381780031314 ()

  • DIA 7.5 x 100mm
61-7500

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 95mm
Seaspine, Inc.
61-7095
Not in Commercial Distribution

  • M5566170951 ()
  • 10381780031307 ()

  • DIA 7.0 x 95mm
61-7095

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 90mm
Seaspine, Inc.
61-7090
Not in Commercial Distribution

  • M5566170901 ()
  • 10381780031291 ()

  • DIA 7.0 x 90mm
61-7090

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 85mm
Seaspine, Inc.
61-7085
Not in Commercial Distribution

  • M5566170851 ()
  • 10381780031284 ()

  • DIA 7.0 x 85mm
61-7085

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 80mm
Seaspine, Inc.
61-7080
Not in Commercial Distribution

  • M5566170801 ()
  • 10381780031277 ()

  • DIA 7.0 x 80mm
61-7080

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 75mm
Seaspine, Inc.
61-7075
Not in Commercial Distribution

  • M5566170751 ()
  • 10381780031260 ()

  • DIA 7.0 x 75mm
61-7075

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 70mm
Seaspine, Inc.
61-7070
Not in Commercial Distribution

  • M5566170701 ()
  • 10381780031253 ()

  • DIA 7.0 x 70mm
61-7070

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 65mm
Seaspine, Inc.
61-7065
Not in Commercial Distribution

  • M5566170651 ()
  • 10381780031246 ()

  • DIA 7.0 x 65mm
61-7065

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 60mm
Seaspine, Inc.
61-7060
Not in Commercial Distribution

  • M5566170601 ()
  • 10381780031239 ()

  • DIA 7.0 x 60mm
61-7060

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 55mm
Seaspine, Inc.
61-7055
Not in Commercial Distribution

  • M5566170551 ()
  • 10381780031222 ()

  • DIA 7.0 x 55mm
61-7055

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 50mm
Seaspine, Inc.
61-7050
Not in Commercial Distribution

  • M5566170501 ()
  • 10381780031215 ()

  • DIA 7.0 x 50mm
61-7050

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 45mm
Seaspine, Inc.
61-7045
Not in Commercial Distribution

  • M5566170451 ()
  • 10381780031208 ()

  • DIA 7.0 x 45mm
61-7045

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 40mm
Seaspine, Inc.
61-7040
Not in Commercial Distribution

  • M5566170401 ()
  • 10381780031192 ()

  • DIA 7.0 x 40mm
61-7040

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 35mm
Seaspine, Inc.
61-7035
Not in Commercial Distribution

  • M5566170351 ()
  • 10381780031185 ()

  • DIA 7.0 x 35mm
61-7035

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 30mm
Seaspine, Inc.
61-7030
Not in Commercial Distribution

  • M5566170301 ()
  • 10381780031178 ()

  • DIA 7.0 x 30mm
61-7030

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 110mm
Seaspine, Inc.
61-7010
Not in Commercial Distribution

  • M5566170101 ()
  • 10381780031161 ()

  • DIA 7.0 x 110mm
61-7010

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 105mm
Seaspine, Inc.
61-7005
Not in Commercial Distribution

  • M5566170051 ()
  • 10381780031154 ()

  • DIA 7.0 x 105mm
61-7005

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 100mm
Seaspine, Inc.
61-7000
Not in Commercial Distribution

  • M5566170001 ()
  • 10381780031147 ()

  • DIA 7.0 x 100mm
61-7000

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 6.5 x 95mm
Seaspine, Inc.
61-6595
Not in Commercial Distribution

  • M5566165951 ()
  • 10381780031130 ()

  • DIA 6.5 x 95mm
61-6595

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 6.5 x 90mm
Seaspine, Inc.
61-6590
Not in Commercial Distribution

  • M5566165901 ()
  • 10381780031123 ()

  • DIA 6.5 x 90mm
61-6590

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 6.5 x 85mm
Seaspine, Inc.
61-6585
Not in Commercial Distribution

  • M5566165851 ()
  • 10381780031116 ()

  • DIA 6.5 x 85mm
61-6585

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 6.5 x 80mm
Seaspine, Inc.
61-6580
Not in Commercial Distribution

  • M5566165801 ()
  • 10381780031109 ()

  • DIA 6.5 x 80mm
61-6580

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 6.5 x 75mm
Seaspine, Inc.
61-6575
Not in Commercial Distribution

  • M5566165751 ()
  • 10381780031093 ()

  • DIA 6.5 x 75mm
61-6575

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 6.5 x 70mm
Seaspine, Inc.
61-6570
Not in Commercial Distribution

  • M5566165701 ()
  • 10381780031086 ()

  • DIA 6.5 x 70mm
61-6570

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 6.5 x 65mm
Seaspine, Inc.
61-6565
Not in Commercial Distribution

  • M5566165651 ()
  • 10381780031079 ()

  • DIA 6.5 x 65mm
61-6565

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 6.5 x 60mm
Seaspine, Inc.
61-6560
Not in Commercial Distribution

  • M5566165601 ()
  • 10381780031062 ()

  • DIA 6.5 x 60mm
61-6560

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 6.5 x 55mm
Seaspine, Inc.
61-6555
Not in Commercial Distribution

  • M5566165551 ()
  • 10381780031055 ()

  • DIA 6.5 x 55mm
61-6555

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 6.5 x 50mm
Seaspine, Inc.
61-6550
Not in Commercial Distribution

  • M5566165501 ()
  • 10381780031048 ()

  • DIA 6.5 x 50mm
61-6550

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 6.5 x 45mm
Seaspine, Inc.
61-6545
Not in Commercial Distribution

  • M5566165451 ()
  • 10381780031031 ()

  • DIA 6.5 x 45mm
61-6545

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 6.5 x 40mm
Seaspine, Inc.
61-6540
Not in Commercial Distribution

  • M5566165401 ()
  • 10381780031024 ()

  • DIA 6.5 x 40mm
61-6540

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 6.5 x 35mm
Seaspine, Inc.
61-6535
Not in Commercial Distribution

  • M5566165351 ()
  • 10381780031017 ()

  • DIA 6.5 x 35mm
61-6535

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