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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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Odalys - 03700406302636

The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Polyaxial screw Ø6 L55
In Commercial Distribution

  • 03700406302636 ()
ODPS55655

  • Bone-screw internal spinal fixation system, non-sterile

Odalys - 03700406302629

The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Polyaxial screw Ø5 L55
In Commercial Distribution

  • 03700406302629 ()
ODPS55555

  • Bone-screw internal spinal fixation system, non-sterile

Odalys - 03700406302612

The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Polyaxial screw Ø7 L55
In Commercial Distribution

  • 03700406302612 ()
ODPS55755

  • Bone-screw internal spinal fixation system, non-sterile

Odalys - 03700406301769

The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Polyaxial spondylolisthesis screw Ø7 L55
In Commercial Distribution

  • 03700406301769 ()
ODSS55755

  • Bone-screw internal spinal fixation system, non-sterile

Odalys - 03700406301745

The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Polyaxial spondylolisthesis screw Ø6 L55
In Commercial Distribution

  • 03700406301745 ()
ODSS55655

  • Bone-screw internal spinal fixation system, non-sterile

Fixone Instrument - 08800039100656

This device is used to drill a hole.
AJU PHARM. CO., LTD.
Fixone.I.S-D/B300
In Commercial Distribution

  • 08800039100656 ()


  • Fluted surgical drill bit, single-use

Integra® External Fixation System - 10381780124986

The k-wire washer is used in conjunction with the Integra External Fixation System. It is made from stainless steel.
Ascension Orthopedics, Inc.
12220025
In Commercial Distribution

  • 10381780124986 ()

  • .394 in dia x .039 in H
12220025

  • External orthopaedic fixation system, reusable

CAPTURE™ Screw System - 10381780117339

The Capture Headless screw is a cannulated, dual-thread, headless bone screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AH3034
In Commercial Distribution

  • 10381780117339 ()
  • M268AH30341 ()

  • 1.339 in L x .121 in dia; .650 in thread
AH3034

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

CAPTURE™ Screw System - 10381780117308

The Capture Headless screw is a cannulated, dual-thread, headless bone screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AH3028
In Commercial Distribution

  • 10381780117308 ()
  • M268AH30281 ()

  • 1.102 in L x .121 in dia; .530 in thread
AH3028

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

CAPTURE™ Screw System - 10381780117162

The Capture Headless screw is a cannulated, dual-thread, headless bone screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AH2510
In Commercial Distribution

  • 10381780117162 ()
  • M268AH25101 ()

  • .397 in L x .101 in dia; .170 in thread
AH2510

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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