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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Modular Shankdriver, Robot
ALPHATEC SPINE, INC.
525-16420
In Commercial Distribution

  • 00190376540061 ()


  • Surgical screwdriver, reusable
8 mm Hex Driver
ALPHATEC SPINE, INC.
525-08-01
In Commercial Distribution

  • 00190376539904 ()


  • Neurological stereotactic surgery system
Locking Access Screwdriver
ALPHATEC SPINE, INC.
360-160
In Commercial Distribution

  • 00190376537344 ()


  • Surgical screwdriver, reusable
Access Screwdriver
ALPHATEC SPINE, INC.
360-150
In Commercial Distribution

  • 00190376537337 ()


  • Surgical screwdriver, reusable
Splay Driver
ALPHATEC SPINE, INC.
360-050
In Commercial Distribution

  • 00190376537283 ()


  • Surgical screwdriver, reusable
CCX Expansion Driver
ALPHATEC SPINE, INC.
327-300
In Commercial Distribution

  • 00190376532271 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Lag Driver
FUSION ORTHOPEDICS, LLC
TN-MF-3035
In Commercial Distribution

  • 00840124519916 ()
TN-MF-3035

  • Surgical screwdriver, reusable
Short Torx Driver
FUSION ORTHOPEDICS, LLC
TN-MF-3125
In Commercial Distribution

  • 00840124519909 ()
TN-MF-3125

  • Surgical screwdriver, reusable
Torx Driver
FUSION ORTHOPEDICS, LLC
TN-MF-3025
In Commercial Distribution

  • 00840124519893 ()
TN-MF-3025

  • Surgical screwdriver, reusable
Short Driver Torx
FUSION ORTHOPEDICS, LLC
TN-SB-3125
In Commercial Distribution

  • 00840124519640 ()
TN-SB-3125

  • Surgical screwdriver, reusable
Driver Torx SB
FUSION ORTHOPEDICS, LLC
TN-SB-3025
In Commercial Distribution

  • 00840124519633 ()
TN-SB-3025

  • Surgical screwdriver, reusable
25mm Tray Based Inserter
FUSION ORTHOPEDICS, LLC
TN-DB-2525
In Commercial Distribution

  • 00840124519114 ()
TN-DB-2525

  • Orthopaedic bone staple driver
20mm Tray Based Inserter
FUSION ORTHOPEDICS, LLC
TN-DB-2020
In Commercial Distribution

  • 00840124519107 ()
TN-DB-2020

  • Orthopaedic bone staple driver
18mm Tray Based Inserter
FUSION ORTHOPEDICS, LLC
TN-DB-1818
In Commercial Distribution

  • 00840124519091 ()
TN-DB-1818

  • Orthopaedic bone staple driver
15mm tray Based Inserter
FUSION ORTHOPEDICS, LLC
TN-DB-1515
In Commercial Distribution

  • 00840124519084 ()
TN-DB-1515

  • Orthopaedic bone staple driver
13mm Tray Based Inserter
FUSION ORTHOPEDICS, LLC
TN-DB-1313
In Commercial Distribution

  • 00840124519077 ()
TN-DB-1313

  • Orthopaedic bone staple driver
11mm Tray Based Inserter
FUSION ORTHOPEDICS, LLC
TN-DB-1111
In Commercial Distribution

  • 00840124519060 ()
TN-DB-1111

  • Orthopaedic bone staple driver
9mm Tray Based Inserter
FUSION ORTHOPEDICS, LLC
TN-DB-0909
In Commercial Distribution

  • 00840124519053 ()
TN-DB-0909

  • Orthopaedic bone staple driver
Non-Ratcheting Driver Handle (NOT IN USE)
FUSION ORTHOPEDICS, LLC
TN-FX-6020
In Commercial Distribution

  • 00840124518766 ()
TN-FX-6020

  • Orthopaedic osteotome handle
Ratcheting Driver Handle
FUSION ORTHOPEDICS, LLC
TN-FX-6010
In Commercial Distribution

  • 00840124518759 ()
TN-FX-6010

  • Orthopaedic osteotome handle
Drill PEEK Cannulated Anchor 4.75mm
FUSION ORTHOPEDICS, LLC
CD-TL-1545
In Commercial Distribution

  • 00840124518568 ()
CD-TL-1545

  • Cannulated surgical drill bit, single-use
Three Prong Right Offset Inserter (Sterile)
FUSION ORTHOPEDICS, LLC
CD-DB-35I0-S
In Commercial Distribution

  • 00840124517813 ()
CD-DB-35I0-S

  • Orthopaedic bone staple driver
Cannulated Driver 2.5mm
FUSION ORTHOPEDICS, LLC
CD-CS-3025
In Commercial Distribution

  • 00840124514416 ()
CD-CS-3025

  • Surgical screwdriver, single-use
Cannulated Drill 2.5mm (1.7mm)
FUSION ORTHOPEDICS, LLC
CD-CS-1025
In Commercial Distribution

  • 00840124514393 ()
CD-CS-1025

  • Cannulated surgical drill bit, single-use
Three Prong T Offset Inserter (Sterile)
FUSION ORTHOPEDICS, LLC
CD-DB-3OI0-S
In Commercial Distribution

  • 00840124513662 ()
CD-DB-3OI0-S

  • Orthopaedic bone staple driver
Three Prong T Inserter (Sterile)
FUSION ORTHOPEDICS, LLC
CD-DB-3TI0-S
In Commercial Distribution

  • 00840124513655 ()
CD-DB-3TI0-S

  • Orthopaedic bone staple driver
Four Prong Straight Inserter (Sterile)
FUSION ORTHOPEDICS, LLC
CD-DB-4SI0-S
In Commercial Distribution

  • 00840124513648 ()
CD-DB-4SI0-S

  • Orthopaedic bone staple driver
Four Prong T Inserter (Sterile)
FUSION ORTHOPEDICS, LLC
CD-DB-4TI0-S
In Commercial Distribution

  • 00840124513631 ()
CD-DB-4TI0-S

  • Orthopaedic bone staple driver
Calc Slide Inserter 14mm (Sterile)
FUSION ORTHOPEDICS, LLC
CD-DB-CI14-S
In Commercial Distribution

  • 00840124513624 ()
CD-DB-CI14-S

  • Orthopaedic bone staple driver
Calc Slide Inserter 12mm (Sterile)
FUSION ORTHOPEDICS, LLC
CD-DB-CI12-S
In Commercial Distribution

  • 00840124513617 ()
CD-DB-CI12-S

  • Orthopaedic bone staple driver
Calc Slide Inserter 10mm (Sterile)
FUSION ORTHOPEDICS, LLC
CD-DB-CI10-S
In Commercial Distribution

  • 00840124513600 ()
CD-DB-CI10-S

  • Orthopaedic bone staple driver
Calc Slide Inserter 8mm (Sterile)
FUSION ORTHOPEDICS, LLC
CD-DB-CI08-S
In Commercial Distribution

  • 00840124513594 ()
CD-DB-CI08-S

  • Orthopaedic bone staple driver
Calc Slide Inserter 6mm (Sterile)
FUSION ORTHOPEDICS, LLC
CD-DB-CI06-S
In Commercial Distribution

  • 00840124513587 ()
CD-DB-CI06-S

  • Orthopaedic bone staple driver
Calc Slide Inserter 4mm (Sterile)
FUSION ORTHOPEDICS, LLC
CD-DB-CI04-S
In Commercial Distribution

  • 00840124513570 ()
CD-DB-CI04-S

  • Orthopaedic bone staple driver
Three Prong T Offset Inserter
FUSION ORTHOPEDICS, LLC
CD-DB-3OI0
In Commercial Distribution

  • 00840124513464 ()
CD-DB-3OI0

  • Orthopaedic bone staple driver
Three Prong T Inserter
FUSION ORTHOPEDICS, LLC
CD-DB-3TI0
In Commercial Distribution

  • 00840124513457 ()
CD-DB-3TI0

  • Orthopaedic bone staple driver
Four Prong Straight Inserter
FUSION ORTHOPEDICS, LLC
CD-DB-4SI0
In Commercial Distribution

  • 00840124513440 ()
CD-DB-4SI0

  • Orthopaedic bone staple driver
Four Prong T Inserter
FUSION ORTHOPEDICS, LLC
CD-DB-4TI0
In Commercial Distribution

  • 00840124513433 ()
CD-DB-4TI0

  • Orthopaedic bone staple driver
Calc Slide Inserter 14mm
FUSION ORTHOPEDICS, LLC
CD-DB-CI14
In Commercial Distribution

  • 00840124513426 ()
CD-DB-CI14

  • Orthopaedic bone staple driver
Calc Slide Inserter 12mm
FUSION ORTHOPEDICS, LLC
CD-DB-CI12
In Commercial Distribution

  • 00840124513419 ()
CD-DB-CI12

  • Orthopaedic bone staple driver
Calc Slide Inserter 10mm
FUSION ORTHOPEDICS, LLC
CD-DB-CI10
In Commercial Distribution

  • 00840124513402 ()
CD-DB-CI10

  • Orthopaedic bone staple driver
Calc Slide Inserter 8mm
FUSION ORTHOPEDICS, LLC
CD-DB-CI08
In Commercial Distribution

  • 00840124513396 ()
CD-DB-CI08

  • Orthopaedic bone staple driver
Calc Slide Inserter 6mm
FUSION ORTHOPEDICS, LLC
CD-DB-CI06
In Commercial Distribution

  • 00840124513389 ()
CD-DB-CI06

  • Orthopaedic bone staple driver
Calc Slide Inserter 4mm
FUSION ORTHOPEDICS, LLC
CD-DB-CI04
In Commercial Distribution

  • 00840124513372 ()
CD-DB-CI04

  • Orthopaedic bone staple driver
Driver Torx FT 7.0mm
FUSION ORTHOPEDICS, LLC
CD-FT-3070
In Commercial Distribution

  • 00840124512795 ()
CD-FT-3070

  • Surgical screwdriver, single-use
Driver Torx FT 5.5mm
FUSION ORTHOPEDICS, LLC
CD-FT-3055
In Commercial Distribution

  • 00840124512788 ()
CD-FT-3055

  • Surgical screwdriver, single-use
HT 2X Driver (4.5mm)
FUSION ORTHOPEDICS, LLC
TN-2X-3045
In Commercial Distribution

  • 00840124511835 ()


  • Surgical screwdriver, single-use
HT 2X Driver (3.4mm)
FUSION ORTHOPEDICS, LLC
TN-2X-3034
In Commercial Distribution

  • 00840124511828 ()


  • Surgical screwdriver, single-use
HT 2X Driver (2.6mm)
FUSION ORTHOPEDICS, LLC
TN-2X-3026
In Commercial Distribution

  • 00840124511811 ()


  • Surgical screwdriver, single-use
HT 2X Thread Drill (2.2mm)
FUSION ORTHOPEDICS, LLC
CD-2X-1022
In Commercial Distribution

  • 00840124511804 ()


  • Cannulated surgical drill bit, single-use
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