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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Affinium 3D Coated Tibial Tray, Right Medial, Size 1
Engage UNI LLC
1-10012-150
In Commercial Distribution

  • B6951100121500 ()


  • Unicondylar knee prosthesis
Affinium 3D Coated Tibial Tray, Left Medial, Size 1
Engage UNI LLC
1-10012-100
In Commercial Distribution

  • B6951100121000 ()


  • Unicondylar knee prosthesis
Tibial Anchor Stem, Size 5-6
Engage UNI LLC
1-10011-300
In Commercial Distribution

  • B6951100113000 ()


  • Unicondylar knee prosthesis
Tibial Anchor Stem, Size 3-4
Engage UNI LLC
1-10011-200
In Commercial Distribution

  • B6951100112000 ()


  • Unicondylar knee prosthesis
Tibial Anchor Stem, Size 1-2
Engage UNI LLC
1-10011-100
In Commercial Distribution

  • B6951100111000 ()


  • Unicondylar knee prosthesis
GENESIS II POSTERIOR STABILIZED NONPOR OXINIUM SIZE 9 LEFT
Smith & Nephew, Inc.
71930008
In Commercial Distribution

  • 03596010511430 ()
71930008

  • Unicondylar knee prosthesis
PROFIX OXINIUM POSTERIOR STABILIZED FEM SZ 7 RT
Smith & Nephew, Inc.
71523177
Not in Commercial Distribution

  • 03596010488596 ()
71523177

  • Unicondylar knee prosthesis
PROFIX OXINIUM POSTERIOR STABILIZED FEM SZ 7 LT
Smith & Nephew, Inc.
71523277
Not in Commercial Distribution

  • 03596010488589 ()
71523277

  • Unicondylar knee prosthesis
PROFIX OXINIUM POSTERIOR STABILIZED FEM SZ 6 RT
Smith & Nephew, Inc.
71523167
Not in Commercial Distribution

  • 03596010488572 ()
71523167

  • Unicondylar knee prosthesis
PROFIX OXINIUM POSTERIOR STABILIZED FEM SZ 6 LT
Smith & Nephew, Inc.
71523267
Not in Commercial Distribution

  • 03596010488565 ()
71523267

  • Unicondylar knee prosthesis
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