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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Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 14, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1401
In Commercial Distribution

  • M7161111814010 ()
111-18-1401

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 13, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1301
In Commercial Distribution

  • M7161111813010 ()
111-18-1301

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 12, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1201
In Commercial Distribution

  • M7161111812010 ()
111-18-1201

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 11, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1101
In Commercial Distribution

  • M7161111811010 ()
111-18-1101

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 10, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1001
In Commercial Distribution

  • M7161111810010 ()
111-18-1001

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 9, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-0901
In Commercial Distribution

  • M7161111809010 ()
111-18-0901

  • Press-fit femoral stem prosthesis
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1825
In Commercial Distribution

  • 09348215024109 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1625
In Commercial Distribution

  • 09348215024093 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1525
In Commercial Distribution

  • 09348215024086 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1425
In Commercial Distribution

  • 09348215024079 ()


  • Coated femoral stem prosthesis, modular
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