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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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iNSitu™ Hip System - 00816127025181

Medial/Lateral Compaction Broach, Size 9
NEXTSTEP ARTHROPEDIX, LLC
10-80-0509
In Commercial Distribution

  • 00816127025181 ()


  • Orthopaedic broach

iNSitu Total Hip System - 00816127024870

Cemented Femoral Stem, Size 9, Lateralized
NEXTSTEP ARTHROPEDIX, LLC
10-16-0009
In Commercial Distribution

  • 00816127024870 ()


  • Uncoated hip femur prosthesis, modular

iNSitu Total Hip System - 00816127024726

Cemented Femoral Stem, Size 9, Standard
NEXTSTEP ARTHROPEDIX, LLC
10-15-0009
In Commercial Distribution

  • 00816127024726 ()


  • Uncoated hip femur prosthesis, modular

Anatomic Shoulder Prosthesis - 07630040706032

Standard Humeral Diaphysis – Cementless, Size 9
Medacta International SA
04.01.0004
In Commercial Distribution

  • 07630040706032 ()


  • Total shoulder prosthesis

Surgical Direct - B382SD9146531320

9” Cone Ring Curette, 8mm, Angled
Surgical Direct, Inc.
SD914653132
In Commercial Distribution

  • B382SD9146531320 ()
SD914653132

  • Bone curette, reusable

Surgical Direct - B382SD9146531110

9” Cone Ring Curette, Straight, 6mm
Surgical Direct, Inc.
SD914653111
In Commercial Distribution

  • B382SD9146531110 ()
SD914653111

  • Bone curette, reusable

Surgical Direct - B382SD9146344000

9” Bruns Curette, Straight Size 00000
Surgical Direct, Inc.
SD914634400
In Commercial Distribution

  • B382SD9146344000 ()
SD914634400

  • Bone curette, reusable

Surgical Direct - B382SD9146343030

9" Bruns Curette, Straight, Size 6
Surgical Direct, Inc.
SD914634303
In Commercial Distribution

  • B382SD9146343030 ()
SD914634303

  • Bone curette, reusable

Surgical Direct - B382SD9144821500

9" Lambotte Osteotome Straight, 15mm Blade
Surgical Direct, Inc.
SD914482150
In Commercial Distribution

  • B382SD9144821500 ()
SD914482150

  • Orthopaedic osteotome

Surgical Direct - B382SDM435080

9 inch Bruns Curette, Size 5
Surgical Direct, Inc.
SDM43508
In Commercial Distribution

  • B382SDM435080 ()
SDM43508

  • Bone curette, reusable
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