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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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MESA Spinal System - 10888857271326

Screw Head Elevator Two Sided
K2M, INC.
6201-90080
In Commercial Distribution

  • 10888857271326 ()
6201-90080

  • Bone lever/elevator, reusable

Medtronic Reusable Instruments - 00613994974112

SCREWDRIVER EX0311257 6.35 TWO PIECE
MEDTRONIC SOFAMOR DANEK, INC.
EX0311257
In Commercial Distribution

  • 00613994974112 ()


  • Orthopaedic implant driver

Sternal Cable System - 00846468040697

SS Two Pack Sternal Crimps
Pioneer Surgical Technology, Inc.
400-401
Not in Commercial Distribution

  • 00846468040697 ()


  • Internal spinal fixation system cable

Sternal Cable System - 00846468041182

Ti Two Pack Sternal Crimps
Pioneer Surgical Technology, Inc.
408-723
Not in Commercial Distribution

  • 00846468041182 ()


  • Internal spinal fixation system cable

MESA Small Stature Spinal System - 10888857378612

Screw Head Elevator Two Sided
K2M, INC.
3001-90161
In Commercial Distribution

  • 10888857378612 ()
3001-90161

  • Orthopaedic prosthesis implantation positioning instrument, reusable

GPC - 08904400201673

Wire Twister with Two Pegs
GPC MEDICAL LIMITED
IPW942
In Commercial Distribution

  • 08904400201673 ()


  • General external orthopaedic fixation system implantation kit, reusable

ACE - 00614950022205

TWO PIECE TREPHINE KNURLED HOLDER
ACE SURGICAL SUPPLY CO., INC.
04941301
In Commercial Distribution

  • 00614950022205 ()
04941301

  • Bone trephine set

ASPECT®* ANTERIOR CERVICAL PLATE SYSTEM - 00846468050917

Two Level, Standard Plate, 41mm
Pioneer Surgical Technology, Inc.
27-241
Not in Commercial Distribution

  • 00846468050917 ()
27-241

  • Bone-screw internal spinal fixation system, non-sterile
  • Spinal fixation plate, non-bioabsorbable

ASPECT®* ANTERIOR CERVICAL PLATE SYSTEM - 00846468050894

Two Level, Standard Plate, 36mm
Pioneer Surgical Technology, Inc.
27-236
Not in Commercial Distribution

  • 00846468050894 ()
27-236

  • Bone-screw internal spinal fixation system, non-sterile
  • Spinal fixation plate, non-bioabsorbable

ASPECT®* ANTERIOR CERVICAL PLATE SYSTEM - 00846468050863

Two Level, Standard Plate, 30mm
Pioneer Surgical Technology, Inc.
27-230
Not in Commercial Distribution

  • 00846468050863 ()
27-230

  • Bone-screw internal spinal fixation system, non-sterile
  • Spinal fixation plate, non-bioabsorbable
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