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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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ELEOS™ - B27818056008E0

TRIAL FEMORAL HEAD 32MM OD +0MM
ONKOS SURGICAL, INC.
18056008E
In Commercial Distribution

  • B27818056008E0 ()
18056008E

  • General internal orthopaedic fixation system implantation kit

ELEOS™ - B27818056007E0

TRIAL FEMORAL HEAD 32MM OD -3.5MM
ONKOS SURGICAL, INC.
18056007E
In Commercial Distribution

  • B27818056007E0 ()
18056007E

  • General internal orthopaedic fixation system implantation kit

ELEOS™ - B27818052206E0

TRIAL FEMORAL HEAD 22MM OD +3.5MM
ONKOS SURGICAL, INC.
18052206E
In Commercial Distribution

  • B27818052206E0 ()
18052206E

  • General internal orthopaedic fixation system implantation kit

ELEOS™ - B27818052205E0

TRIAL FEMORAL HEAD 22MM OD +0MM
ONKOS SURGICAL, INC.
18052205E
In Commercial Distribution

  • B27818052205E0 ()
18052205E

  • General internal orthopaedic fixation system implantation kit

Large QWIX - 10381780064459

The Large QWIX positioning and fixation screws were designed for extremity fixation, to provide speed and precision for challenging surgical situations. The QWIX screw is a cannulated, fully threaded screw with a self-tapping screw tip. Instruments are also provided.
NEWDEAL
QWX57INSTSET
Not in Commercial Distribution

  • 10381780064459 ()
  • M248QWX57INSTSET1 ()
QWX57INSTSET

  • General internal orthopaedic fixation system implantation kit

UNI-CLIP - 10381780064435

The Large Uni-Clip Staple is a staple so that, by widening the diamond shaped opening, mechanical deformation leads to narrowing of the interaxis of the two legs. The surgeon can obtain a true compression, adjustable and controlled with many choice of size. The Large Uni-Clip Staple is indicated for fixation of bone fractures or for bone reconstruction. The set includes the staples and instruments.
NEWDEAL
LGUNICPINST
Not in Commercial Distribution

  • 10381780064435 ()
  • M248LGUNICPINST1 ()
LGUNICPINST

  • General internal orthopaedic fixation system implantation kit

I.CO.S - 10381780064428

The I.CO.S Screw is a cannulated compression screw with non-threaded shaft, allowing optimal compression. The head of this screw can be screwed and translated along the body in order to increase the compression controlled by the surgeon. It also has a self-tapping screw tip. The I.CO.S screw is indicated for fixing the elective osteotomies of the forefoot and/or mid foot bones and for fractures fixation. This set includes I.CO.S screws that are 6mm in diameter. Instruments are also provided.
NEWDEAL
ICOS6INSTSET
Not in Commercial Distribution

  • 10381780064428 ()
  • M248ICOS6INSTSET1 ()
ICOS6INSTSET

  • General internal orthopaedic fixation system implantation kit

HALLU-FIX - 10381780064404

The Hallu-Fix set includes Hallu-Fix S Plates, Hallu-Fix C Plates, screws, and instruments. The Hallu Plates are low profile titanium plates dedicated to first metatarsophalangeal arthrodesis. The system is intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metatarsophalangeal joint.
NEWDEAL
HALUINSTSET
Not in Commercial Distribution

  • 10381780064404 ()
  • M248HALUINSTSET1 ()
HALUINSTSET

  • General internal orthopaedic fixation system implantation kit

Forefoot - 10381780064398

The principal of the FOREFOOT sets is to propose a group of implants (screws and staples) and the associated instruments in a single package dedicated to the forefoot orthopaedic surgery. The set is intended to make easy the surgeon work and give more solution in the same set. The Forefoot Set includes Bold compression screws, QWIX fixation screws, Spin snap-off screws, Solustaple, Uni-clip staples, and instrumentation.
NEWDEAL
FFINSTSET
Not in Commercial Distribution

  • 10381780064398 ()
  • M248FFINSTSET1 ()
FFINSTSET

  • General internal orthopaedic fixation system implantation kit

QWIX - 10381780064442

The QWIX positioning and fixation screw are designed to provide speed and precision for challenging surgical situations. They are indicated for fixation of bone fractures or for bone reconstructions. QWIX 3.0 and 4.3 are designed with self-drilling flutes. The compression screw has a non-threaded shaft and a self-tapping screw tip. Instruments are also provided.
NEWDEAL
QWX34INSTSET
Not in Commercial Distribution

  • 10381780064442 ()
  • M248QWX34INSTSET1 ()
QWX34INSTSET

  • General internal orthopaedic fixation system implantation kit
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