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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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T15 RETAINING DRIVER, SHORT
ORTHOPEDIATRICS CORP.
01-0903-0005
In Commercial Distribution

  • 00841132122273 ()
01-0903-0005

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Set Screw Starter, Retaining, Dual-Ended
Xtant Medical Holdings, Inc.
1505-000460
In Commercial Distribution

  • 00840311251810 ()


  • Surgical screwdriver, reusable
Final Driver, Connector
Xtant Medical Holdings, Inc.
1505-000900
In Commercial Distribution

  • 00840311251803 ()


  • Surgical screwdriver, reusable
Cervalign, Rigid Screw Inserter, Sleeve
Xtant Medical Holdings, Inc.
725-092
In Commercial Distribution

  • 00840311247912 ()


  • Surgical screwdriver, reusable
STREAMLINE OCT, RIGID SCREW INSERTER
Surgalign Spine Technologies, Inc.
724-983
In Commercial Distribution

  • 00840311240920 ()


  • Surgical screwdriver, reusable
Passive Locking Inserter
Xtant Medical Holdings, Inc.
26-SCREWINSRTR-4
In Commercial Distribution

  • 00840311240562 ()


  • Surgical screwdriver, reusable
SCREW INSERTER
Xtant Medical Holdings, Inc.
26-SCREWINSRTR-2
In Commercial Distribution

  • 00840311240555 ()


  • Surgical screwdriver, reusable
SCREW INSERTER
Xtant Medical Holdings, Inc.
26-SCREWINSRTR
In Commercial Distribution

  • 00840311240548 ()


  • Surgical screwdriver, reusable
Final Driver, Rod-to-Rod Crosslink
Xtant Medical Holdings, Inc.
26-R2R-XLINK-DRVR
In Commercial Distribution

  • 00840311240357 ()


  • Surgical screwdriver, reusable
Final Driver, Split Tip, OCP
Xtant Medical Holdings, Inc.
26-OCPSTFLDRVR
In Commercial Distribution

  • 00840311239337 ()


  • Surgical screwdriver, reusable
Tap, Stubby, OCP
Xtant Medical Holdings, Inc.
26-OCPSTBTAP
In Commercial Distribution

  • 00840311239320 ()


  • Surgical screwdriver, reusable
Screwdriver, Stubby, OCP
Xtant Medical Holdings, Inc.
26-OCPSTBDRVR
In Commercial Distribution

  • 00840311239313 ()


  • Surgical screwdriver, reusable
Screwdriver, Flex, OCP
Xtant Medical Holdings, Inc.
26-OCPFLXDRVR
In Commercial Distribution

  • 00840311238866 ()


  • Surgical screwdriver, reusable
Screwdriver, STD, OCP
Xtant Medical Holdings, Inc.
26-OCPDRVR
In Commercial Distribution

  • 00840311238835 ()


  • Surgical screwdriver, reusable
Final Driver, Head-to-Head Crosslink
Xtant Medical Holdings, Inc.
26-H2H-XLINK-DRVR
In Commercial Distribution

  • 00840311238170 ()


  • Surgical screwdriver, reusable
Final Locker, Gen. 2
Xtant Medical Holdings, Inc.
26-FNLDRIVER-2
In Commercial Distribution

  • 00840311237975 ()


  • Surgical screwdriver, reusable
FINAL LOCKER
Xtant Medical Holdings, Inc.
26-FNLDRIVER
In Commercial Distribution

  • 00840311237968 ()


  • Surgical screwdriver, reusable
Dorsal Height Adjuster
Xtant Medical Holdings, Inc.
26-DORSALADJUSTR
In Commercial Distribution

  • 00840311237883 ()


  • Surgical screwdriver, reusable
Locker
Xtant Medical Holdings, Inc.
25-LOCKER
In Commercial Distribution

  • 00840311232864 ()


  • Surgical screwdriver, reusable
Driver, Nav, Poly, Shaft, Solid, Jcb
Surgalign Spine Technologies, Inc.
1505-800603
In Commercial Distribution

  • 00840311232567 ()


  • Surgical screwdriver, reusable
Flexible Drilling Shaft, 60°, Assembly
Shalby Advanced Technologies, Inc.
1801-1-1215
In Commercial Distribution

  • 00840286855631 ()

  • Flexible Drilling Shaft, 60°, Assembly
1801-1-1215

  • Surgical screwdriver, reusable
UJ Screwdriver, Assembly, 3.5 Hex
Shalby Advanced Technologies, Inc.
1801-0-1350
In Commercial Distribution

  • 00840286855624 ()

  • UJ Screwdriver, Assembly, 3.5 Hex
1801-0-1350

  • Surgical screwdriver, reusable
Straight Hex Screwdriver
Shalby Advanced Technologies, Inc.
1801-0-1340
In Commercial Distribution

  • 00840286855617 ()

  • Straight Hex Screwdriver
1801-0-1340

  • Surgical screwdriver, reusable
Fixation Pin, w/Cut-Out, Ø 3.2mm., 4" Long
Shalby Advanced Technologies, Inc.
2800-1-1432
In Commercial Distribution

  • 00840286855167 ()

  • Fixation Pin, w/Cut-Out, Ø 3.2mm., 4" Long
2800-1-1432

  • Orthopaedic intraoperative positioning pin, reusable
Fixation Pin, w/Cutout, Ø 3.2mm, 3" Long
Shalby Advanced Technologies, Inc.
2800-1-1332
In Commercial Distribution

  • 00840286855150 ()

  • Fixation Pin, w/Cutout, Ø 3.2mm, 3" Long
2800-1-1332

  • Orthopaedic intraoperative positioning pin, reusable
Fixation Pin w/Cutout, Ø 3.2mm, 2" Long
Shalby Advanced Technologies, Inc.
2800-1-1232
In Commercial Distribution

  • 00840286855143 ()

  • Fixation Pin w/Cutout, Ø 3.2mm, 2" Long
2800-1-1232

  • Orthopaedic intraoperative positioning pin, reusable
Fixation Pin, Tri-Face, Ø 3.2mm, 2" Long
Shalby Advanced Technologies, Inc.
2800-0-2232
In Commercial Distribution

  • 00840286855136 ()

  • Fixation Pin, Tri-Face, Ø 3.2mm, 2" Long
2800-0-2232

  • Orthopaedic intraoperative positioning pin, reusable
Fixation Pin, Ø 3.2mm, 4" Long
Shalby Advanced Technologies, Inc.
2800-0-0432
In Commercial Distribution

  • 00840286855068 ()

  • Fixation Pin, Ø 3.2mm, 4" Long
2800-0-0432

  • Orthopaedic intraoperative positioning pin, reusable
Fixation Pin, Ø 3.2mm, 3" Long
Shalby Advanced Technologies, Inc.
2800-0-0332
In Commercial Distribution

  • 00840286855051 ()

  • Fixation Pin, Ø 3.2mm, 3" Long
2800-0-0332

  • Orthopaedic intraoperative positioning pin, reusable
Fixation Pin, Ø 3.2mm, 2" Long
Shalby Advanced Technologies, Inc.
2800-0-0232
In Commercial Distribution

  • 00840286855044 ()

  • Fixation Pin, Ø 3.2mm, 2" Long
2800-0-0232

  • Orthopaedic intraoperative positioning pin, reusable
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