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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Calibrated Solid Overdrill SB 2.4mm
FUSION ORTHOPEDICS, LLC
CD-SB-1524
In Commercial Distribution

  • 00840124500808 ()
CD-SB-1524

  • Cannulated surgical drill bit, single-use, non-sterile
Calibrated Drill Solid SB 2.4mm
FUSION ORTHOPEDICS, LLC
CD-SB-1024
In Commercial Distribution

  • 00840124500785 ()
CD-SB-1024

  • Cannulated surgical drill bit, single-use, non-sterile
Calibrated Solid Overdrill SB 2.0mm
FUSION ORTHOPEDICS, LLC
CD-SB-1520
In Commercial Distribution

  • 00840124500754 ()
CD-SB-1520

  • Cannulated surgical drill bit, single-use, non-sterile
Modular Shankdriver, MIS, Robot
ALPHATEC SPINE, INC.
525-16421
In Commercial Distribution

  • 00190376540085 ()


  • Surgical screwdriver, reusable
Modular Shankdriver, Power, Robot
ALPHATEC SPINE, INC.
525-16420-RJ
In Commercial Distribution

  • 00190376540078 ()


  • Surgical screwdriver, reusable
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
3.5mm Locking Turret
FUSION ORTHOPEDICS, LLC
TN-MF-5035
In Commercial Distribution

  • 00840124520165 ()
TN-MF-5035

  • Bone screw fixation sleeve
CCX Expansion Driver
ALPHATEC SPINE, INC.
327-300
In Commercial Distribution

  • 00190376532271 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Universal Window Joint Seeker
FUSION ORTHOPEDICS, LLC
TN-MF-7052
In Commercial Distribution

  • 00840124520011 ()
TN-MF-7052

  • Bone screw fixation sleeve
Universal Straight Cut Creator
FUSION ORTHOPEDICS, LLC
TN-MF-7051
In Commercial Distribution

  • 00840124520004 ()
TN-MF-7051

  • Bone screw fixation sleeve
Universal Cutting Window
FUSION ORTHOPEDICS, LLC
TN-MF-7050
In Commercial Distribution

  • 00840124519992 ()
TN-MF-7050

  • Bone screw fixation sleeve
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
TailorsLock Lag Turret
FUSION ORTHOPEDICS, LLC
TN-TB-7004
In Commercial Distribution

  • 00840124519770 ()
TN-TB-7004

  • Bone screw fixation sleeve
TailorsLock Turret
FUSION ORTHOPEDICS, LLC
TN-TB-7003
In Commercial Distribution

  • 00840124519756 ()
TN-TB-7003

  • Bone screw fixation sleeve
MiniLock Turrets
FUSION ORTHOPEDICS, LLC
TN-SB-7003
In Commercial Distribution

  • 00840124519725 ()
TN-SB-7003

  • Bone screw fixation sleeve
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
2.7mm Locking Turret SB
FUSION ORTHOPEDICS, LLC
TN-SB-5027
In Commercial Distribution

  • 00840124519626 ()
TN-SB-5027

  • Bone screw fixation sleeve
2.4mm LockingTurret SB
FUSION ORTHOPEDICS, LLC
TN-SB-5024
In Commercial Distribution

  • 00840124519596 ()
TN-SB-5024

  • Bone screw fixation sleeve
Window 6mm LapiLock Tissue Protector
FUSION ORTHOPEDICS, LLC
TN-LL-5860
In Commercial Distribution

  • 00840124519213 ()
TN-LL-5860

  • Bone screw fixation sleeve
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
4.5mm Tissue Protector
FUSION ORTHOPEDICS, LLC
TN-FT-9145
In Commercial Distribution

  • 00840124519039 ()
TN-FT-9145

  • Bone screw fixation sleeve
3.5mm Tissue Protector
FUSION ORTHOPEDICS, LLC
TN-FT-9135
In Commercial Distribution

  • 00840124519022 ()
TN-FT-9135

  • Bone screw fixation sleeve
2.5mm Tissue Protector
FUSION ORTHOPEDICS, LLC
TN-FT-9125
In Commercial Distribution

  • 00840124519015 ()
TN-FT-9125

  • Bone screw fixation sleeve
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
4.0mm Tissue Protector
FUSION ORTHOPEDICS, LLC
TN-CS-8040
In Commercial Distribution

  • 00840124518513 ()
TN-CS-8040

  • Bone screw fixation sleeve
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