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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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Tapered Screw Driver, 4.0 Hex, Short, ZH QC
ORTHOPEDIATRICS CORP.
01-1510-0043
In Commercial Distribution

  • 00840194428675 ()
01-1510-0043

  • Surgical screwdriver, reusable
T15 Screw Driver - Retaining
ORTHOPEDIATRICS CORP.
01-1600-4003
In Commercial Distribution

  • 00840194428538 ()
01-1600-4003

  • Surgical screwdriver, reusable
Cervical Final Driver
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910025005 ()
91.002.5005

  • Internal spinal fixation procedure kit, single-use
Casper Pin Driver
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555910021005 ()
91.002.1005

  • Internal spinal fixation procedure kit, reusable
Final Tightening Driver
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555507000003 ()
50-7000-003

  • Internal spinal fixation procedure kit, reusable
Driver, Polyaxial, 11in
AMEDICA CORPORATION
X
Not in Commercial Distribution

  • M555503000011 ()

  • Length: 11 Inch
50-3000-011

  • Internal spinal fixation procedure kit, reusable
Driver, Polyaxial, Reduction, Long
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555503000009 ()
50-3000-009

  • Internal spinal fixation procedure kit, reusable
Driver, Polyaxial, Long
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555503000008 ()
50-3000-008

  • Internal spinal fixation procedure kit, reusable
Driver, Headless, 10in
AMEDICA CORPORATION
C
Not in Commercial Distribution

  • M555503000007 ()
50-3000-007

  • Internal spinal fixation procedure kit, reusable
120° Adolescent Straight Plate, 16-Hole
ORTHOPEDIATRICS CORP.
00-3002-3216
In Commercial Distribution

  • 00840194473347 ()
00-3002-3216

  • Femoral neck fixation plate/sleeve
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