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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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TERRA NOVA MI Access System - 10888857185821

Hook Retractor Size 90 mm
K2M, INC.
K2-15-2022-06
In Commercial Distribution

  • 10888857185821 ()
K2-15-2022-06

  • Surgical retractor/retraction system blade, reusable

TERRA NOVA MI Access System - 10888857185814

Hook Retractor Size 80 mm
K2M, INC.
K2-15-2022-05
In Commercial Distribution

  • 10888857185814 ()
K2-15-2022-05

  • Surgical retractor/retraction system blade, reusable

TERRA NOVA MI Access System - 10888857185807

Hook Retractor Size 70 mm
K2M, INC.
K2-15-2022-04
In Commercial Distribution

  • 10888857185807 ()
K2-15-2022-04

  • Surgical retractor/retraction system blade, reusable

TERRA NOVA MI Access System - 10888857185791

Hook Retractor Size 60 mm
K2M, INC.
K2-15-2022-03
In Commercial Distribution

  • 10888857185791 ()
K2-15-2022-03

  • Surgical retractor/retraction system blade, reusable

TERRA NOVA MI Access System - 10888857185784

Hook Retractor Size 50 mm
K2M, INC.
K2-15-2022-02
In Commercial Distribution

  • 10888857185784 ()
K2-15-2022-02

  • Surgical retractor/retraction system blade, reusable

TERRA NOVA MI Access System - 10888857185777

Hook Retractor Size 40 mm
K2M, INC.
K2-15-2022-01
In Commercial Distribution

  • 10888857185777 ()
K2-15-2022-01

  • Surgical retractor/retraction system blade, reusable

DENALI MI Spinal System - 10888857185494

NiTi Guidewire Size .044 X 20.5 IN
K2M, INC.
K2-10-2239-01
In Commercial Distribution

  • 10888857185494 ()
K2-10-2239-01

  • Internal spinal fixation procedure kit, single-use

ALEUTIAN® Interbody Systems - 10888857184589

Lordotic Trial, Size 28x36x21 mm, 10°
K2M, INC.
K2-07-2105-07
In Commercial Distribution

  • 10888857184589 ()

  • Length: 28 Millimeter
  • Height: 21 Millimeter
  • Width: 36 Millimeter
  • Angle: 10 degree
K2-07-2105-07

  • General internal orthopaedic fixation system implantation kit

ALEUTIAN® Interbody Systems - 10888857184572

Lordotic Trial, Size 28x36x19 mm, 10°
K2M, INC.
K2-07-2105-06
In Commercial Distribution

  • 10888857184572 ()

  • Width: 36 Millimeter
  • Height: 19 Millimeter
  • Angle: 10 degree
  • Length: 28 Millimeter
K2-07-2105-06

  • General internal orthopaedic fixation system implantation kit

ALEUTIAN® Interbody Systems - 10888857184565

Lordotic Trial, Size 28x36x17 mm, 10°
K2M, INC.
K2-07-2105-05
In Commercial Distribution

  • 10888857184565 ()

  • Length: 28 Millimeter
  • Angle: 10 degree
  • Width: 36 Millimeter
  • Height: 17 Millimeter
K2-07-2105-05

  • General internal orthopaedic fixation system implantation kit
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