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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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OSferion - 04560245656951

OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. OSferion is to be used as a bone replacement material and has properties that allow it to be replaced by autogenous bone after implantation. The porosity of OSferion is 60%. Products are supplied in wedges and trapezoids.
OLYMPUS TERUMO BIOMATERIALS CORP.
AR-13372-1
In Commercial Distribution

  • 04560245656951 ()

  • Angle: 75 degree
  • Length: 7 Millimeter
  • Length: 25 Millimeter
  • Length: 8 Millimeter
AR-13372-1

  • Bone matrix implant, synthetic, non-antimicrobial

OSferion - 04560245656913

OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. OSferion is to be used as a bone replacement material and has properties that allow it to be replaced by autogenous bone after implantation. The porosity of OSferion is 60%. Products are supplied in wedges and trapezoids.
OLYMPUS TERUMO BIOMATERIALS CORP.
AR-13370-4
In Commercial Distribution

  • 04560245656913 ()

  • Length: 12 Millimeter
  • Length: 35 Millimeter
  • Length: 3 Millimeter
  • Length: 15 Millimeter
AR-13370-4

  • Bone matrix implant, synthetic, non-antimicrobial

OSferion - 04560245656906

OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. OSferion is to be used as a bone replacement material and has properties that allow it to be replaced by autogenous bone after implantation. The porosity of OSferion is 60%. Products are supplied in wedges and trapezoids.
OLYMPUS TERUMO BIOMATERIALS CORP.
AR-13370-3
In Commercial Distribution

  • 04560245656906 ()

  • Length: 12 Millimeter
  • Length: 35 Millimeter
  • Length: 3 Millimeter
  • Length: 12 Millimeter
AR-13370-3

  • Bone matrix implant, synthetic, non-antimicrobial

OSferion - 04560245656883

OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. OSferion is to be used as a bone replacement material and has properties that allow it to be replaced by autogenous bone after implantation. The porosity of OSferion is 60%. Products are supplied in wedges and trapezoids.
OLYMPUS TERUMO BIOMATERIALS CORP.
AR-13370-1
In Commercial Distribution

  • 04560245656883 ()

  • Length: 12 Millimeter
  • Length: 30 Millimeter
  • Length: 3 Millimeter
  • Length: 7 Millimeter
AR-13370-1

  • Bone matrix implant, synthetic, non-antimicrobial

OSferion - 04560245656890

OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. OSferion is to be used as a bone replacement material and has properties that allow it to be replaced by autogenous bone after implantation. The porosity of OSferion is 60%. Products are supplied in wedges and trapezoids.
OLYMPUS TERUMO BIOMATERIALS CORP.
AR-13370-2
In Commercial Distribution

  • 04560245656890 ()

  • Length: 12 Millimeter
  • Length: 30 Millimeter
  • Length: 3 Millimeter
  • Length: 10 Millimeter
AR-13370-2

  • Bone matrix implant, synthetic, non-antimicrobial

Arthrex - 10889981153694

AlloSync CB DBM Putty, 10cc Vial
ISOTIS ORTHOBIOLOGICS, INC.
ABS-2014-10
In Commercial Distribution

  • 10889981153694 ()

  • 10cc
ABS-2014-10

  • Bone matrix implant, human-derived

Arthrex - 10889981153687

AlloSync CB DBM Putty, 5cc Vial
ISOTIS ORTHOBIOLOGICS, INC.
ABS-2014-05
In Commercial Distribution

  • 10889981153687 ()

  • 5cc
ABS-2014-05

  • Bone matrix implant, human-derived

Arthrex - 10889981153670

AlloSync CB DBM Paste, 8cc Syringe
ISOTIS ORTHOBIOLOGICS, INC.
ABS-2015-08
In Commercial Distribution

  • 10889981153670 ()

  • 8cc
ABS-2015-08

  • Bone matrix implant, human-derived

Arthrex - 10889981153663

AlloSync CB DBM Paste, 3cc Syringe
ISOTIS ORTHOBIOLOGICS, INC.
ABS-2015-03
In Commercial Distribution

  • 10889981153663 ()

  • 3cc
ABS-2015-03

  • Bone matrix implant, human-derived

Arthrex - 10889981153656

AlloSync CB DBM Paste, 1cc Syringe
ISOTIS ORTHOBIOLOGICS, INC.
ABS-2015-01
In Commercial Distribution

  • 10889981153656 ()

  • 1cc
ABS-2015-01

  • Bone matrix implant, human-derived
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