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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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Excella II® - M711LS1710

SST
Innovasis, Inc.
LS-171
In Commercial Distribution

  • M711LS1710 ()
LS-171

  • Surgical screwdriver, reusable

Excella III-D® - M711LS0430

SST
Innovasis, Inc.
LS-043
In Commercial Distribution

  • M711LS0430 ()
LS-043

  • Surgical screwdriver, reusable

Xpress Minimally Invasive Pedicle Screw System - M697T07319001

SCREW RE-ENGAGEMENT TOOL
Xtant Medical Holdings, Inc.
T073-1900
In Commercial Distribution

  • M697T07319000 ()
  • M697T07319001 ()


  • Surgical screwdriver, reusable

X90 Pedicle Screw System - M697N600016201

Twist Driver, Assembly
Xtant Medical Holdings, Inc.
N60001620
In Commercial Distribution

  • M697N600016200 ()
  • M697N600016201 ()


  • Surgical screwdriver, reusable

X90 Pedicle Screw System - M697N600016101

Flex Locking Screwdriver, X90, Assy
Xtant Medical Holdings, Inc.
N60001610
In Commercial Distribution

  • M697N600016100 ()
  • M697N600016101 ()


  • Surgical screwdriver, reusable

X90 Pedicle Screw System - M697N600015781

CAM SCREWDRIVER THUMB WHEEL
Xtant Medical Holdings, Inc.
N60001578
In Commercial Distribution

  • M697N600015780 ()
  • M697N600015781 ()


  • Surgical screwdriver, reusable

X90 Pedicle Screw System - M697N600015771

CAM SCREWDRIVER FORK SLEEVE
Xtant Medical Holdings, Inc.
N60001577
In Commercial Distribution

  • M697N600015770 ()
  • M697N600015771 ()


  • Surgical screwdriver, reusable

X90 Pedicle Screw System - M697N600015761

CAM SCREWDRIVER HEX SHAFT
Xtant Medical Holdings, Inc.
N60001576
In Commercial Distribution

  • M697N600015760 ()
  • M697N600015761 ()


  • Surgical screwdriver, reusable

X90 Pedicle Screw System - M697N600015541

FINAL LOCKING WRENCH, 1/4" SQUARE
Xtant Medical Holdings, Inc.
N60001554
In Commercial Distribution

  • M697N600015540 ()
  • M697N600015541 ()


  • Surgical screwdriver, reusable

X90 Pedicle Screw System - M697CN6000251

Specialty X-90 Adjustment Driver
Xtant Medical Holdings, Inc.
CN60-0025
In Commercial Distribution

  • M697CN6000250 ()
  • M697CN6000251 ()


  • Surgical screwdriver, reusable
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