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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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Torque Driver Handle
Xtant Medical Holdings, Inc.
N60000478
In Commercial Distribution

  • M697N600004780 ()
  • M697N600004781 ()


  • Surgical instrument handle, torque-limiting
Screwdriver Assembly
Xtant Medical Holdings, Inc.
N60000475
In Commercial Distribution

  • M697N600004750 ()
  • M697N600004751 ()


  • Surgical screwdriver, reusable
Specialty Locking Pedicle Screwdriver
Xtant Medical Holdings, Inc.
CN60-0026
In Commercial Distribution

  • M697CN6000260 ()
  • M697CN6000261 ()


  • Surgical screwdriver, reusable
Specialty X-90 Reducer Wrench Assembly
Xtant Medical Holdings, Inc.
CN60-0021-9
In Commercial Distribution

  • M697CN60002190 ()
  • M697CN60002191 ()


  • Surgical screwdriver, reusable
Irix-A Smooth Driver
Xtant Medical Holdings, Inc.
C080-0107
In Commercial Distribution

  • M697C08001070 ()
  • M697C08001071 ()


  • Surgical screwdriver, reusable
Specialty Unguided Universal Joint Hex Driver
Xtant Medical Holdings, Inc.
C080-0105
In Commercial Distribution

  • M697C08001050 ()
  • M697C08001051 ()


  • Polymeric spinal interbody fusion cage
IRIX A UNIVERSAL JOINT GUIDED HEX DRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
C080-0080
In Commercial Distribution

  • M697C08000800 ()
  • M697C08000801 ()


  • Polymeric spinal interbody fusion cage
SPECIAL 7mm ADJUSTMENT IMPLANT DRIVER, CANNULATED
Xtant Medical Holdings, Inc.
C079-0264
In Commercial Distribution

  • M697C07902640 ()
  • M697C07902641 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
CUSTOM IMPACTION DRIVER
Xtant Medical Holdings, Inc.
C079-0026
In Commercial Distribution

  • M697C07900260 ()
  • M697C07900261 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implant, coated
SPECIALTY 12.5 mm IMPLANT DRIVER
Xtant Medical Holdings, Inc.
C079-0011
In Commercial Distribution

  • M697C07900110 ()
  • M697C07900111 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
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