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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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6.5MM EN BLOC IM REAMER
ORTHOPEDIATRICS CORP.
01-1501-0065
In Commercial Distribution

  • 00841132150061 ()
01-1501-0065

  • Medullary canal orthopaedic reamer shaft
T-HANDLE HEX DRIVER, CANNULATED
ORTHOPEDIATRICS CORP.
01-1501-0024
In Commercial Distribution

  • 00841132150382 ()
01-1501-0024

  • Surgical screwdriver, single-use
ZipE® Knotless Tissue Repair and Attachment Devices - A6-6545-S 4.5 mm titanium screw, 6.5 resorbable capture, #2 braided suture, and driver Qty. 6
ZIPTEK LLC
A6-6545-S
In Commercial Distribution

  • 10858816006030 ()


  • Tendon/ligament bone anchor, non-bioabsorbable
ZipE® Knotless Tissue Repair and Attachment Devices 5.0 mm titanium screw, 6.5 resorbable capture, #2 braided suture, and driver Qty. 6
ZIPTEK LLC
A6-6550-S
In Commercial Distribution

  • 10858816006023 ()


  • Tendon/ligament bone anchor, non-bioabsorbable
ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6565-S 6.5 mm resorbable plug, 6.5 mm resorbable capture, #2 braided suture, and driver Qty. 6
ZIPTEK LLC
RA6-6565-S
In Commercial Distribution

  • 10858816006016 ()


  • Tendon/ligament bone anchor, bioabsorbable
ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6550-S 5.0 mm resorbable plug, 6.5 mm resorbable capture, #2 braided suture, and driver Qty. 6
ZIPTEK LLC
RA6-6550-S
In Commercial Distribution

  • 10858816006009 ()


  • Tendon/ligament bone anchor, bioabsorbable
No Description
WRIGHT MEDICAL TECHNOLOGY, INC.
RR007DRS
Not in Commercial Distribution

  • 00840420153319 ()


  • External orthopaedic fixation system, reusable
Star 15 Driver
WRIGHT MEDICAL TECHNOLOGY, INC.
SMN10006
In Commercial Distribution

  • 00840420194794 ()
SMN10006

  • Orthopaedic implant driver
Snap-Off Screw Driver
WRIGHT MEDICAL TECHNOLOGY, INC.
45112000
In Commercial Distribution

  • 00840420190642 ()
45112000

  • Orthopaedic implant driver
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
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