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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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U2 Total Knee System - 04719872157199

Tibial punch, #0~#2
UNITED ORTHOPEDIC CORP.
9404-6001
In Commercial Distribution

  • 04719872157199 ()

  • #0~#2
9404-6001

  • Orthopaedic broach

U2™ Hip - 04719872171706

Osteotomy guide, #2-#7
UNITED ORTHOPEDIC CORP.
9104-2012
In Commercial Distribution

  • 04719872171706 ()

  • #2-#7
9104-2012

  • Osteotomy guide, reusable

Ascend - 00846832025077

HUMERAL DISTAL TRIAL
TORNIER, INC.
SH070202
In Commercial Distribution

  • 00846832025077 ()

  • Size 2
SH070202

  • Humeral stem prosthesis trial, reusable

Tornier Simpliciti - 00846832024896

Fin Blazer Trial
TORNIER, INC.
9722892
In Commercial Distribution

  • 00846832024896 ()

  • Size 2
9722892

  • Humeral stem prosthesis trial, reusable

Tornier Simpliciti - 00846832024865

Surface Planer
TORNIER, INC.
9722888
In Commercial Distribution

  • 00846832024865 ()

  • Size 2
9722888

  • Bone-resection orthopaedic reamer, reusable

Affiniti - 00846832022595

LATERAL CUT GUIDE - CUT BLOCK
TORNIER, INC.
9000394
Not in Commercial Distribution

  • 00846832022595 ()

  • Size #2
9000394

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Ascend - 00846832022472

HUMERAL CUT PROTECTOR
TORNIER, INC.
SH107202
In Commercial Distribution

  • 00846832022472 ()

  • Size 2
SH107202

  • Surgical instrument guard, reusable

Tornier Simpliciti - 00846832022168

Humeral Cut Protector
TORNIER, INC.
9722897
In Commercial Distribution

  • 00846832022168 ()

  • Size 2
9722897

  • Surgical instrument guard, reusable

Tornier Simpliciti - 00846832022090

Sizer Disk
TORNIER, INC.
9722882
In Commercial Distribution

  • 00846832022090 ()

  • Size 2
9722882

  • Surgical implant template, reusable

UTF Hip Stem - 04719872172710

UTF Stem, case #2
UNITED ORTHOPEDIC CORP.
9106-8020-RA
In Commercial Distribution

  • 04719872172710 ()

  • case #2
9106-8020-RA

  • Instrument tray, reusable
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