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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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SLIMFUSE™* ANTERIOR CERVICAL PLATE SYSTEM - 00846468025793

SCREW DRIVER, INTERNAL SET SCREW
Pioneer Surgical Technology, Inc.
21-FINALDRIV-TL
Not in Commercial Distribution

  • 00846468025793 ()
21-FINALDRIV-TL

  • Surgical screwdriver, reusable

SLIMFUSE™* ANTERIOR CERVICAL PLATE SYSTEM - 00846468025786

SCREW DRIVER, INTERNAL SET SCREW
Pioneer Surgical Technology, Inc.
21-FINALDRIVER
Not in Commercial Distribution

  • 00846468025786 ()
21-FINALDRIVER

  • Surgical screwdriver, reusable

SLIMFUSE™* ANTERIOR CERVICAL PLATE SYSTEM - 00846468025700

SCREW DRIVER, BONE SCREW
Pioneer Surgical Technology, Inc.
21-DRIVER-TF
Not in Commercial Distribution

  • 00846468025700 ()
21-DRIVER-TF

  • Surgical screwdriver, reusable

SLIMFUSE™* ANTERIOR CERVICAL PLATE SYSTEM - 00846468025694

SCREW DRIVER, BONE SCREW
Pioneer Surgical Technology, Inc.
21-DRIVER
Not in Commercial Distribution

  • 00846468025694 ()
21-DRIVER

  • Surgical screwdriver, reusable

Streamline® TL Spinal Fixation System - 00846468006242

INSERTER, SET SCREW
Xtant Medical Holdings, Inc.
02-SETSCRWINS-1
Not in Commercial Distribution

  • 00846468006242 ()
02-SETSCRWINS-1

  • Surgical screwdriver, reusable

Streamline® TL Spinal Fixation System - 00846468006235

REDUCTION SCREW INSERTER
Xtant Medical Holdings, Inc.
02-SCREWINSRTR
Not in Commercial Distribution

  • 00846468006235 ()
02-SCREWINSRTR

  • Surgical screwdriver, reusable

Streamline® TL Spinal Fixation System - 00846468074906

Reduction Tower
Xtant Medical Holdings, Inc.
02-TOWER
Not in Commercial Distribution

  • 00846468074906 ()
02-TOWER

  • Surgical screwdriver, reusable

Streamline® TL Spinal Fixation System - 00846468074869

Reduction Screw Inserter
Xtant Medical Holdings, Inc.
02-RS-INSERTER
Not in Commercial Distribution

  • 00846468074869 ()
02-RS-INSERTER

  • Surgical screwdriver, reusable

Zimmer® Cannulated Screw System - 00846468074272

CANNULATED HEXAGONAL DRIVER, 2.5mm
Pioneer Surgical Technology, Inc.
00-1147-062-00
In Commercial Distribution

  • 00846468074272 ()
00-1147-062-00

  • Surgical screwdriver, reusable

Zimmer® Cannulated Screw System - 00846468074166

CANNULATED DRIVER, 5.0mm HEX
Pioneer Surgical Technology, Inc.
00-1147-049-50
In Commercial Distribution

  • 00846468074166 ()
00-1147-049-50

  • Surgical screwdriver, reusable
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