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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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Quattro® - M543CM9580

No Description
CAYENNE MEDICAL, INC.
CM-9580
In Commercial Distribution

  • M543CM9580 ()
CM-9580

  • Cannulated surgical drill bit, single-use

Quattro® - M543CM9550

No Description
CAYENNE MEDICAL, INC.
CM-9550
In Commercial Distribution

  • M543CM9550 ()
CM-9550

  • Cannulated surgical drill bit, single-use

PNP Femur - 00840194472616

13mm Opening Reamer
ORTHOPEDIATRICS CORP.
01-1501-0093-S
In Commercial Distribution

  • 00840194472616 ()
01-1501-0093-S

  • Medullary canal orthopaedic reamer shaft

PNP Femur - 00840194472609

12mm Opening Reamer
ORTHOPEDIATRICS CORP.
01-1501-0092-S
In Commercial Distribution

  • 00840194472609 ()
01-1501-0092-S

  • Medullary canal orthopaedic reamer shaft

PNP Femur - 00840194472593

11mm Opening Reamer
ORTHOPEDIATRICS CORP.
01-1501-0091-S
In Commercial Distribution

  • 00840194472593 ()
01-1501-0091-S

  • Medullary canal orthopaedic reamer shaft

PNP Femur - 00840194472586

10mm Opening Reamer
ORTHOPEDIATRICS CORP.
01-1501-0090-S
In Commercial Distribution

  • 00840194472586 ()
01-1501-0090-S

  • Medullary canal orthopaedic reamer shaft

PNP Femur - 00840194472401

PNP Screw Easy Off
ORTHOPEDIATRICS CORP.
01-1501-0076-S
In Commercial Distribution

  • 00840194472401 ()
01-1501-0076-S

  • Surgical screwdriver, single-use

Fixone Biocomposite Anchor - 08800039100809

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-55001da
In Commercial Distribution

  • 08800039100809 ()


  • Tendon/ligament bone anchor, bioabsorbable

Fixone Hybrid Anchor - 08800039100601

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.
KAP-55001ca
In Commercial Distribution

  • 08800039100601 ()


  • Tendon/ligament bone anchor, bioabsorbable

Fixone Hybrid Anchor - 08800039100571

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.
KAP-47501ca
In Commercial Distribution

  • 08800039100571 ()


  • Tendon/ligament bone anchor, bioabsorbable
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