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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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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.
SAL-30002i
In Commercial Distribution

  • 08800039100335 ()


  • Tendon/ligament bone anchor, bioabsorbable
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.
KAB-55001ca
In Commercial Distribution

  • 08800039100083 ()


  • Tendon/ligament bone anchor, bioabsorbable
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-55003ch
In Commercial Distribution

  • 08800039100045 ()


  • Tendon/ligament bone anchor, bioabsorbable
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-55002dh
In Commercial Distribution

  • 08800039100038 ()


  • Tendon/ligament bone anchor, bioabsorbable
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
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
MHMDL
In Commercial Distribution

  • 08800039308663 ()


  • Fixture/appliance dental drill bit, reusable
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
MHMDS
In Commercial Distribution

  • 08800039308656 ()


  • Fixture/appliance dental drill bit, reusable
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
MRMDL
In Commercial Distribution

  • 08800039308649 ()


  • Fixture/appliance dental drill bit, reusable
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
MRMDS
In Commercial Distribution

  • 08800039308632 ()


  • Fixture/appliance dental drill bit, reusable
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
RDS
In Commercial Distribution

  • 08800039308625 ()


  • Fixture/appliance dental drill bit, reusable
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
RDL
In Commercial Distribution

  • 08800039308618 ()


  • Fixture/appliance dental drill bit, reusable
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
MHD1.2L
In Commercial Distribution

  • 08800039308496 ()


  • Fixture/appliance dental drill bit, reusable
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
MHD1.2S
In Commercial Distribution

  • 08800039308489 ()


  • Fixture/appliance dental drill bit, reusable
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
SAD
In Commercial Distribution

  • 08800039308472 ()


  • Fixture/appliance dental drill bit, reusable
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
SD05
In Commercial Distribution

  • 08800039308465 ()


  • Fixture/appliance dental drill bit, reusable
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
CHMDL
In Commercial Distribution

  • 08800039308458 ()


  • Fixture/appliance dental drill bit, reusable
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
CHMDS
In Commercial Distribution

  • 08800039308441 ()


  • Fixture/appliance dental drill bit, reusable
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
CMDL
In Commercial Distribution

  • 08800039308434 ()


  • Fixture/appliance dental drill bit, reusable
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
CMDS
In Commercial Distribution

  • 08800039308427 ()


  • Fixture/appliance dental drill bit, reusable
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
MDR
In Commercial Distribution

  • 08800039308410 ()


  • Fixture/appliance dental drill bit, reusable
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
SDWL
In Commercial Distribution

  • 08800039308403 ()


  • Fixture/appliance dental drill bit, reusable
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
SDWS
In Commercial Distribution

  • 08800039308397 ()


  • Fixture/appliance dental drill bit, reusable
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
SDRS
In Commercial Distribution

  • 08800039308380 ()


  • Fixture/appliance dental drill bit, reusable
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
SDRL
In Commercial Distribution

  • 08800039308373 ()


  • Fixture/appliance dental drill bit, reusable
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
HD1.2S
In Commercial Distribution

  • 08800039308366 ()


  • Fixture/appliance dental drill bit, reusable
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
HD1.2L
In Commercial Distribution

  • 08800039308359 ()


  • Fixture/appliance dental drill bit, reusable
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
HD1.2US
In Commercial Distribution

  • 08800039308342 ()


  • Fixture/appliance dental drill bit, reusable
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.
SAL-30002ni
In Commercial Distribution

  • 08800039102308 ()


  • Tendon/ligament bone anchor, bioabsorbable
The Fixone Hybrid Knotless Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and beta-TCP) and nonabsorbable PEEK tip. A nonabsorbable suture manufactured from cobraided UHMWPE only or UHMWPE and PET fibers is inserted into the anchor. The anchor is implanted using a provided driver.
AJU PHARM. CO., LTD.
KAPN-55001nc
In Commercial Distribution

  • 08800039102254 ()


  • Tendon/ligament bone anchor, bioabsorbable
The Fixone Hybrid Knotless Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and beta-TCP) and nonabsorbable PEEK tip. A nonabsorbable suture manufactured from cobraided UHMWPE only or UHMWPE and PET fibers is inserted into the anchor. The anchor is implanted using a provided driver.
AJU PHARM. CO., LTD.
KAPN-47501nc
In Commercial Distribution

  • 08800039102216 ()


  • Tendon/ligament bone anchor, bioabsorbable
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