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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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ASTRA - M824630022M1

ASTRA T22 Hexalobe Driver
SPINECRAFT, LLC
6300-22-M
In Commercial Distribution

  • M824630022M1 ()
6300-22-M

  • General internal orthopaedic fixation system implantation kit

VELOX - M824402005SPS1

VELOX Screwdriver, with Solid Pin, Short Length Driver
SPINECRAFT, LLC
4020-05-SPS
In Commercial Distribution

  • M824402005SPS1 ()
4020-05-SPS

  • General internal orthopaedic fixation system implantation kit

Sterile Spine Pedicle Screw System - B562090675NS0

Cross Connector Driver, Torque Limiting, Axial, 12 in/lbs.
Wishbone Medical, Inc.
62-2679-00
Not in Commercial Distribution

  • B562090675NS0 ()
62-2679-00

  • Surgical torque wrench, reusable

Sterile Spine Pedicle Screw System - B5620906750

Cross Connector Driver, Torque Limiting, Axial, 12 in/lbs.
Wishbone Medical, Inc.
09.0675
Not in Commercial Distribution

  • B5620906750 ()
09.0675

  • Surgical torque wrench, reusable

Sterile Spine Pedicle Screw System - B562090655NS0

Handle, T, Ratchet, 1/4 sq.
Wishbone Medical, Inc.
62-2671-31
Not in Commercial Distribution

  • B562090655NS0 ()
62-2671-31

  • Surgical torque wrench adaptor

Smart Correction - B5620906550

Handle, T, Ratchet, 1/4 sq.
Wishbone Medical, Inc.
09.0655
Not in Commercial Distribution

  • B5620906550 ()
09.0655

  • Surgical torque wrench adaptor

Smart Correction - B56200620048WBNS0

AO Drill Bit 4.8 x 200mm - Non-Sterile
Wishbone Medical, Inc.
00-6200-48-WBNS
Not in Commercial Distribution

  • B56200620048WBNS0 ()


  • Cannulated surgical drill bit, single-use, non-sterile

Smart Correction - B56200620032WBNS0

AO Drill Bit 3.2 x 200mm - Non-Sterile
Wishbone Medical, Inc.
00-6200-32-WBNS
Not in Commercial Distribution

  • B56200620032WBNS0 ()


  • Cannulated surgical drill bit, single-use, non-sterile

Smart Correction - B56200215510WB0

10mm Hex Bolt Socket - Non-Sterile
Wishbone Medical, Inc.
00-2155-10-WB
Not in Commercial Distribution

  • B56200215510WB0 ()
00-2155-10-WB

  • External orthopaedic fixation system, reusable

Smart Correction - B56200205513WB0

13mm Hex Bolt Wrench - Non-Sterile
Wishbone Medical, Inc.
00-2055-13-WB
Not in Commercial Distribution

  • B56200205513WB0 ()
00-2055-13-WB

  • External orthopaedic fixation system, reusable
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