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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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Nakoma - M6863100T21000

Bone Awl Instrument
ALLIANCE PARTNERS LLC
3100T-2100
In Commercial Distribution

  • M6863100T21000 ()

  • Outer Diameter: 2.3 Millimeter
3100T-2100

  • Bone awl, reusable

MEGA PLUS MIS SPINE SYSTEM - 08809763502552

Cannulated Awl
BK MEDITECH CO.,LTD.
11170
In Commercial Distribution

  • 08809763502552 ()


  • Bone awl, reusable

Irix-A Lumbar Integrated Fusion System - M697C08000701

SPECIALTY UNIVERSAL JOINT AWL (STIFFER JOINT)
Xtant Medical Holdings, Inc.
C080-0070
In Commercial Distribution

  • M697C08000700 ()
  • M697C08000701 ()


  • Bone awl, reusable

Irix-C Cervical Integrated Fusion system - M697C06601211

60 Degree Fixed Angle Awl
Xtant Medical Holdings, Inc.
C066-0121
In Commercial Distribution

  • M697C06601210 ()
  • M697C06601211 ()


  • Bone awl, reusable

Irix-C Cervical Integrated Fusion system - M697C06601191

Specialty Self Centering Bent Awl
Xtant Medical Holdings, Inc.
C066-0119
In Commercial Distribution

  • M697C06601190 ()
  • M697C06601191 ()


  • Bone awl, reusable

Irix-A Lumbar Integrated Fusion System - M697T08000561

Irix A Self-Centering Awl
Xtant Medical Holdings, Inc.
T080-0056
In Commercial Distribution

  • M697T08000560 ()
  • M697T08000561 ()


  • Bone awl, reusable

Irix-A Lumbar Integrated Fusion System - M697T08000551

Irix A Universal Joint Awl
Xtant Medical Holdings, Inc.
T080-0055
In Commercial Distribution

  • M697T08000550 ()
  • M697T08000551 ()


  • Bone awl, reusable

Irix-A Lumbar Integrated Fusion System - M697C08001021

Specialty Irix A Fixed Angle Guided AWL Assembly
Xtant Medical Holdings, Inc.
C080-0102
In Commercial Distribution

  • M697C08001020 ()
  • M697C08001021 ()


  • Bone awl, reusable

Excella II® - M711LS0510

Bone Awl, w/ Impact Cap, .146 Tip, Al, Silicone, SST
Innovasis, Inc.
LS-051
In Commercial Distribution

  • M711LS0510 ()

  • Outer Diameter: 0.146 Inch


  • Bone awl, reusable

Excella II® - M711LS0490

SST
Innovasis, Inc.
LS-049
In Commercial Distribution

  • M711LS0490 ()
LS-049

  • Bone awl, reusable
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