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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.
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
MEDINAUT MAX Wire-Pin Driver Attachment
IMEDICOM CO., LTD.
BMA-W10
Not in Commercial Distribution

  • 08800038053052 ()


  • Multi-purpose surgical power tool system, rechargeable battery-powered
No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
MRMDL
In Commercial Distribution

  • 08800039308649 ()


  • Fixture/appliance dental drill bit, reusable
Hexagonal Screwdriver,
Avalign Technologies, Inc.
0-48349
In Commercial Distribution

  • 00190776343279 ()


  • Surgical screwdriver, reusable
Screwdriver
Avalign Technologies, Inc.
0-48352
In Commercial Distribution

  • 00190776343231 ()


  • Surgical screwdriver, reusable
Screwdriver
Avalign Technologies, Inc.
0-48355
In Commercial Distribution

  • 00190776343224 ()


  • Surgical screwdriver, reusable
Toronto Bone Mallet 24 oz
Avalign Technologies, Inc.
25-771102
In Commercial Distribution

  • 00190776339500 ()


  • Surgical mallet
Toronto Bone Mallet Metal, 32oz 2 1/4" end and 1 7/8" end OL 203.2mm (8")
Avalign Technologies, Inc.
85-651
In Commercial Distribution

  • 00190776339494 ()


  • Surgical mallet
Orthopedic Mallet 2lbs
Avalign Technologies, Inc.
0-49762
In Commercial Distribution

  • 00190776339487 ()


  • Surgical mallet
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