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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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Fixone Biocomposite Anchor - 08800039100021

The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor ismanufactured from biodegradable materials (PLGA copolymer and beta-TCP). A nonabsorbable UHMWPE suture is inserted into the anchor. The anchor is implanted using a provided driver. B,N,BN type(Knotted suture anchors) are ‘screw-in’ anchors used alone or in combination with Kc,KcN type(Knotless suture anchors) for soft-tissue repair. Kc,KcN type(Knotless suture anchor) are used for a soft-tissue repair in combination with the B,N,BN type. SL type ‘push-in’ anchors that are ideal for soft-tissue repair in narrow or deep areas. S type are ‘push-in’ anchors that are ideal for soft-tissue repair in the foot, ankle, hand and wrist The Fixone Biocomposite Anchor consists of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The Fixone Biocomposite Anchor is intended to provide secure reattachment of the soft tissue to bone. Devices are provided sterile. Single use only.
AJU PHARM. CO., LTD.
BAB-45003ch
In Commercial Distribution

  • 08800039100021 ()


  • Tendon/ligament bone anchor, bioabsorbable

DELTA - 07613327090185

DELTA 1.7MM PANEL 22X22 CTRSINKSX0.75MM
Stryker Leibinger GmbH & Co. KG
70-92053
In Commercial Distribution

  • 07613327090185 ()

  • 3D Plates: 22x22 Holes
  • Thickness: 0.75 Millimeter
70-92053

  • Craniofacial fixation plate, bioabsorbable

DELTA - 07613327090147

DELTA 1.7MM PANEL 22X22 CTRSINKS X0.5MM
Stryker Leibinger GmbH & Co. KG
70-92052
In Commercial Distribution

  • 07613327090147 ()

  • Thickness: 0.5 Millimeter
  • 3D Plates: 22x22 Holes
70-92052

  • Craniofacial fixation plate, bioabsorbable

NA - 07613327282382

2 H PLATES(2)20mm BHC(1)SD SCREW(10)AXS
Stryker Leibinger GmbH & Co. KG
12-01546S
In Commercial Distribution

  • 07613327282382 ()

  • Thickness: 0.4 Millimeter
12-01546S

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

NA - 07613327282375

2 HOLE PLATES(3)SELF DRILL SCREW(6) AXS
Stryker Leibinger GmbH & Co. KG
12-01540S
In Commercial Distribution

  • 07613327282375 ()

  • Thickness: 0.6 Millimeter
12-01540S

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

NA - 07613327282344

2 HOLE PLATES W/TAB(3) SD SCREW(6) AXS
Stryker Leibinger GmbH & Co. KG
12-01542S
In Commercial Distribution

  • 07613327282344 ()

  • Thickness: 0.4 Millimeter
12-01542S

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

NA - 07613327282337

14mm BHC(1) SELF DRILLLING SCREW(6) AXS
Stryker Leibinger GmbH & Co. KG
12-01548S
In Commercial Distribution

  • 07613327282337 ()

  • Thickness: 0.4 Millimeter
12-01548S

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

NA - 07613327282320

2 H PLATES(2)14mm BHC(1)SD SCREW(10)AXS
Stryker Leibinger GmbH & Co. KG
12-01544S
In Commercial Distribution

  • 07613327282320 ()

  • Thickness: 0.4 Millimeter
12-01544S

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

NA - 07613327282313

2 HOLE PLATES(3) SELF TAPP SCREW(6) AXS
Stryker Leibinger GmbH & Co. KG
12-01541S
In Commercial Distribution

  • 07613327282313 ()

  • Thickness: 0.6 Millimeter
12-01541S

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

DELTA - 07613327543032

DELTA 1.7MM 2 HOLE PLATE, COUNTERSINK, 0.75MM
Stryker Leibinger GmbH & Co. KG
70-92075
In Commercial Distribution

  • 07613327543032 ()

  • Thickness: 0.75 Millimeter
  • Number of Screw Holes: 2.0 Holes
70-92075

  • Craniofacial fixation plate, bioabsorbable
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