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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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APEX PS Knee - 00841690112501

PS femur, uncemented Size 5 Left
Omni Life Science, Inc.
KP-0250L
In Commercial Distribution

  • 00841690112501 ()
KP-0250L

  • Coated knee femur prosthesis

APEX PS Knee - 00841690112150

PS femur, cemented Size 5 Right
Omni Life Science, Inc.
KP-0050R
In Commercial Distribution

  • 00841690112150 ()
KP-0050R

  • Uncoated knee femur prosthesis, metallic

APEX Knee System - 00841690104346

CR Femoral Uncemented, Size 5+ Right
Omni Life Science, Inc.
KC-1455R
In Commercial Distribution

  • 00841690104346 ()
KC-1455R

  • Coated knee femur prosthesis

APEX CR Knee - 00841690104322

CR Femoral Uncemented, Size 5 Right
Omni Life Science, Inc.
KC-1450R
In Commercial Distribution

  • 00841690104322 ()
KC-1450R

  • Coated knee femur prosthesis

OMNI Mod Hip - 00841690102762

OMNI Modular Stem Size 5, 14.5mm
Omni Life Science, Inc.
151455
In Commercial Distribution

  • 00841690102762 ()
151455

  • Coated hip femur prosthesis, modular

OMNI Mod Hip - 00841690102724

OMNI Modular Stem Size 5, 13mm
Omni Life Science, Inc.
151305
In Commercial Distribution

  • 00841690102724 ()
151305

  • Coated hip femur prosthesis, modular

APEX CR Knee - 00841690100881

CR Femoral Cemented, Size 5 Left
Omni Life Science, Inc.
KC-1105L
In Commercial Distribution

  • 00841690100881 ()
KC-1105L

  • Uncoated knee femur prosthesis, metallic

OMNI K1 Hip - 00841690100102

K1 Femoral Stem, Size 5 Lat
Omni Life Science, Inc.
HC-00055
In Commercial Distribution

  • 00841690100102 ()
HC-00055

  • Coated hip femur prosthesis, modular

ROCCIA - 04054896035826

ROCCIA ALIF Cage 21x40x31mm, 5° Lor.
Silony Medical GmbH
S-RAT-21403105-S
In Commercial Distribution

  • 04054896035826 ()

  • Height: 21 Millimeter
  • Width: 40 Millimeter
  • Length: 31 Millimeter
  • Angle: 5 degree
S-RAT-21403105-S

  • Metallic spinal interbody fusion cage

ROCCIA - 04054896035819

ROCCIA ALIF Cage 19x40x31mm, 5° Lor.
Silony Medical GmbH
S-RAT-19403105-S
In Commercial Distribution

  • 04054896035819 ()

  • Angle: 5 degree
  • Height: 19 Millimeter
  • Width: 40 Millimeter
  • Length: 31 Millimeter
S-RAT-19403105-S

  • Metallic spinal interbody fusion cage
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