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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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Ascend - 00846832024100

MONOLITHIC BROACH
TORNIER, INC.
SH070105
In Commercial Distribution

  • 00846832024100 ()

  • Size 5
SH070105

  • Orthopaedic broach

U2™ Knee - 04719872169659

Femoral posterior augment trial, #5, 8mm
UNITED ORTHOPEDIC CORP.
2603-6052
In Commercial Distribution

  • 04719872169659 ()

  • #5, 8mm
2603-6052

  • Knee femur prosthesis trial, reusable

U2™ Knee - 04719872167747

MIS femoral A/P chamfer cutting guide, #5
UNITED ORTHOPEDIC CORP.
9303-2551-RA
In Commercial Distribution

  • 04719872167747 ()

  • #5,MIS
9303-2551-RA

  • Osteotomy guide, reusable

U2™ Knee - 04719872162971

Tibial baseplate trial, PSA, #5
UNITED ORTHOPEDIC CORP.
2203-6050
In Commercial Distribution

  • 04719872162971 ()

  • PSA, #5
2203-6050

  • Knee tibia prosthesis trial, reusable

U2™ Knee - 04719872176169

Tibial cutting jig, 5°, right
UNITED ORTHOPEDIC CORP.
9403-2225-RE
In Commercial Distribution

  • 04719872176169 ()

  • 5°, right
9403-2225-RE

  • Osteotomy guide, reusable

U2™ Knee - 04719872176091

Tibial cutting jig, 5°, left
UNITED ORTHOPEDIC CORP.
9403-2125-RE
In Commercial Distribution

  • 04719872176091 ()

  • 5°, left
9403-2125-RE

  • Osteotomy guide, reusable

U2™ Knee - 04719872174530

Femoral IM alignment guide, 5°, right
UNITED ORTHOPEDIC CORP.
9303-2345
In Commercial Distribution

  • 04719872174530 ()

  • 5°, right
9303-2345

  • Orthopaedic fixation implant alignment tool

U2™ Knee - 04719872174479

Femoral IM alignment guide, 5°, left
UNITED ORTHOPEDIC CORP.
9303-2335
In Commercial Distribution

  • 04719872174479 ()

  • 5°, left
9303-2335

  • Orthopaedic fixation implant alignment tool

U2™ Knee - 04719872174387

Femoral IM alignment guide , 5°, left
UNITED ORTHOPEDIC CORP.
9303-2315
In Commercial Distribution

  • 04719872174387 ()

  • 5°, left
9303-2315

  • Orthopaedic fixation implant alignment tool

U2™ Knee - 04719872174325

Femoral IM alignment guide , 5°, right
UNITED ORTHOPEDIC CORP.
9303-2305
In Commercial Distribution

  • 04719872174325 ()

  • 5°, right
9303-2305

  • Orthopaedic fixation implant alignment tool
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