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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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Tailored-C - 00850018366427

ANTERIOR CERVICAL 3DTI INSERTER WITH STOP
BESPOKE TECHNOLOGIES, LLC
BCI-101
In Commercial Distribution

  • 00850018366427 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

Tailored-C - 00850018366007

ANTERIOR CERVICAL 3DTI INSERTER
BESPOKE TECHNOLOGIES, LLC
BCI-001
In Commercial Distribution

  • 00850018366007 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

S-Core™ - 00850017962446

Cannulated Sizer Set (00850017962354, 00850017962361, 00850017962378, 00850017962385, 00850017962392, 00850017962408, 00850017962415, 00850017962422, 008500179624239)
SUBCHONDRAL SOLUTIONS, INC.
10-1100
In Commercial Distribution

  • 00850017962446 ()
10-1100

  • Orthopaedic bone screw, non-bioabsorbable, sterile

S-Core™ - 00850017962422

T10 Torque Driver
SUBCHONDRAL SOLUTIONS, INC.
10-4010
In Commercial Distribution

  • 00850017962422 ()
10-4010

  • Orthopaedic bone screw, non-bioabsorbable, sterile

S-Core™ - 00850017962415

Size 4 Cannulated Sizer
SUBCHONDRAL SOLUTIONS, INC.
10-1145
In Commercial Distribution

  • 00850017962415 ()
10-1145

  • Orthopaedic bone screw, non-bioabsorbable, sterile

S-Core™ - 00850017962408

Size 5 Cannulated Sizer
SUBCHONDRAL SOLUTIONS, INC.
10-1155
In Commercial Distribution

  • 00850017962408 ()
10-1155

  • Orthopaedic bone screw, non-bioabsorbable, sterile

S-Core™ - 00850017962392

Size 6 Cannulated Sizer
SUBCHONDRAL SOLUTIONS, INC.
10-1165
In Commercial Distribution

  • 00850017962392 ()
10-1165

  • Orthopaedic bone screw, non-bioabsorbable, sterile

S-Core™ - 00850017962385

Size 7 Cannulated Sizer
SUBCHONDRAL SOLUTIONS, INC.
10-1175
In Commercial Distribution

  • 00850017962385 ()
10-1175

  • Orthopaedic bone screw, non-bioabsorbable, sterile

S-Core™ - 00850017962378

Size 8 Cannulated Sizer
SUBCHONDRAL SOLUTIONS, INC.
10-1185
In Commercial Distribution

  • 00850017962378 ()
10-1185

  • Orthopaedic bone screw, non-bioabsorbable, sterile

S-Core™ - 00850017962361

Size 9 Cannulated Sizer
SUBCHONDRAL SOLUTIONS, INC.
10-1195
In Commercial Distribution

  • 00850017962361 ()
10-1195

  • Orthopaedic bone screw, non-bioabsorbable, sterile
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