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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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Swedge Pedicle Screw Fixation System - B51521130

Screw Driver Removal/Advance Tool, Solid
SPINAL RESOURCES, INC.
2-113
In Commercial Distribution

  • B51521130 ()


  • General internal orthopaedic fixation system implantation kit

Swedge Pedicle Screw Fixation System - B51521110

MIS Polyscrew Driver, Cannulated
SPINAL RESOURCES, INC.
2-111
In Commercial Distribution

  • B51521110 ()


  • General internal orthopaedic fixation system implantation kit

Black Diamond Pedicle Screw System - B0621010104109

OSSEUS HEXALOBE T20 MIS REPLACEABLE TIP
Osseus Fusion Systems, LLC
1010-1041-09
In Commercial Distribution

  • B0621010104109 ()
1010-1041-09

  • Surgical screwdriver, reusable

Black Diamond Pedicle Screw System - B06210101041

SCREW INSERTER, T20, MIS, BLK DIAMOND
Osseus Fusion Systems, LLC
1010-1041
In Commercial Distribution

  • B06210101041 ()
1010-1041

  • Surgical screwdriver, reusable

Black Diamond Pedicle Screw System - B06210101040

SCREW ADJUSTER, BLK DIAMOND
Osseus Fusion Systems, LLC
1010-1040
In Commercial Distribution

  • B06210101040 ()
1010-1040

  • Surgical screwdriver, reusable

Black Diamond Pedicle Screw System - B06210101037

DOUBLE SET SCREW STARTER, BLK DIAMOND
Osseus Fusion Systems, LLC
1010-1037
In Commercial Distribution

  • B06210101037 ()
1010-1037

  • Surgical screwdriver, reusable

Black Diamond Pedicle Screw System - B06210101034

FINAL TIGHTENER, BLK DIAMOND
Osseus Fusion Systems, LLC
1010-1034
In Commercial Distribution

  • B06210101034 ()
1010-1034

  • Surgical screwdriver, reusable

Black Diamond Pedicle Screw System - B06210101033

ROD PASSER TIGHTENER, BLK DIAMOND
Osseus Fusion Systems, LLC
1010-1033
In Commercial Distribution

  • B06210101033 ()
1010-1033

  • Surgical screwdriver, reusable

Black Diamond Pedicle Screw System - B06210101022

SCREW INSERTER, T20, OPEN, BLK DIAMOND
Osseus Fusion Systems, LLC
1010-1022
In Commercial Distribution

  • B06210101022 ()
1010-1022

  • Surgical screwdriver, reusable

Black Diamond Pedicle Screw System - B06210101014

INITIAL SET SCREW DRIVER, BLK DIAMOND
Osseus Fusion Systems, LLC
1010-1014
In Commercial Distribution

  • B06210101014 ()
1010-1014

  • Surgical screwdriver, reusable
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