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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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Aleutian Interbody System - 10888857413139

Modular Trial Size 7
K2M, INC.
SP-3099-01
Not in Commercial Distribution

  • 10888857413139 ()
SP-3099-01

  • General internal orthopaedic fixation system implantation kit

CASPIAN Spinal System - 10888857413016

Universal Joint Drill Size Ø4.3 mm
K2M, INC.
1101-90336
In Commercial Distribution

  • 10888857413016 ()
1101-90336

  • Manual surgical rotary handpiece, reusable

CASPIAN Spinal System - 10888857413009

Universal Joint Drill Size Ø3.8 mm
K2M, INC.
1101-90335
In Commercial Distribution

  • 10888857413009 ()
1101-90335

  • Manual surgical rotary handpiece, reusable

CASPIAN Spinal System - 10888857412996

Occipital Straight Drill Size Ø4.3 mm
K2M, INC.
1101-90334
In Commercial Distribution

  • 10888857412996 ()
1101-90334

  • Manual surgical rotary handpiece, reusable

CASPIAN Spinal System - 10888857412989

Occipital Straight Drill Size Ø3.8 mm
K2M, INC.
1101-90333
In Commercial Distribution

  • 10888857412989 ()
1101-90333

  • Manual surgical rotary handpiece, reusable

Brainlab Compatible K2M Navigation Instruments - 10888857405523

Polyaxial Screw Inserter MESA 2
K2M, INC.
6201-N90001-B
In Commercial Distribution

  • 10888857405523 ()
6201-N90001-B

  • Orthopaedic inorganic implant inserter/extractor, reusable

Brainlab Compatible K2M Navigation Instruments - 10888857405493

Locking Screw Inserter EVEREST XTOWER
K2M, INC.
5101-N90223-B
In Commercial Distribution

  • 10888857405493 ()
5101-N90223-B

  • Orthopaedic inorganic implant inserter/extractor, reusable

Brainlab Compatible K2M Navigation Instruments - 10888857405486

Locking Screw Inserter EVEREST
K2M, INC.
2901-N90098-B
In Commercial Distribution

  • 10888857405486 ()
2901-N90098-B

  • Orthopaedic inorganic implant inserter/extractor, reusable

Cascadia™ Interbody System - 10888857403895

AN MI Inserter Size 10 mm Lordotic-Oblique
K2M, INC.
SP-3032
Not in Commercial Distribution

  • 10888857403895 ()

  • Width: 10 Millimeter
SP-3032

  • Orthopaedic prosthesis implantation positioning instrument, reusable

KEYS™ MI Anterior Deformity Spinal System - 10888857403888

Fixed Handle
K2M, INC.
4601-90061
Not in Commercial Distribution

  • 10888857403888 ()
4601-90061

  • Surgical instrument handle, non-torque-limiting
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