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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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The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal head dorsally. The implant is fixed by means of a stem, which is inserted into the metatarsal intramedullary canal. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012007
Not in Commercial Distribution

  • M2480120071 ()
  • 10381780065449 ()

  • .93 in L x .759 in W; Size 3
012007

  • Partial metatarsophalangeal joint prosthesis
The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal head dorsally. The implant is fixed by means of a stem, which is inserted into the metatarsal intramedullary canal. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012006
Not in Commercial Distribution

  • M2480120061 ()
  • 10381780065432 ()

  • .93 in L x .759 in W; Size 3
012006

  • Partial metatarsophalangeal joint prosthesis
The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal head dorsally. The implant is fixed by means of a stem, which is inserted into the metatarsal intramedullary canal. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012005
Not in Commercial Distribution

  • M2480120051 ()
  • 10381780065425 ()

  • .89 in L x .733 in W; Size 2
012005

  • Partial metatarsophalangeal joint prosthesis
The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal head dorsally. The implant is fixed by means of a stem, which is inserted into the metatarsal intramedullary canal. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012004
Not in Commercial Distribution

  • M2480120041 ()
  • 10381780065418 ()

  • .89 in L x .733 in W; Size 2
012004

  • Partial metatarsophalangeal joint prosthesis
The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal head dorsally. The implant is fixed by means of a stem, which is inserted into the metatarsal intramedullary canal. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012003
Not in Commercial Distribution

  • M2480120031 ()
  • 10381780065401 ()

  • .85 in L x .696 in W; Size 1
012003

  • Partial metatarsophalangeal joint prosthesis
The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal head dorsally. The implant is fixed by means of a stem, which is inserted into the metatarsal intramedullary canal. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012002
Not in Commercial Distribution

  • M2480120021 ()
  • 10381780065395 ()

  • .85 in L x .696 in W; Size 1
012002

  • Partial metatarsophalangeal joint prosthesis
CUSA® Excel 36 kHz CEM™ Nosecone
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C6636
In Commercial Distribution

  • 30381780026130 ()
  • 10381780026136 ()
  • M269C66361 ()

  • 36 kHz frequency
C6636

  • Ultrasonic surgical system adaptor, single-use
CUSA® Excel 23 kHz CEM™ Nosecone
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C6623
In Commercial Distribution

  • 30381780026123 ()
  • 10381780026129 ()
  • M269C66231 ()

  • 23 kHz frequency
C6623

  • Ultrasonic surgical system adaptor, single-use
CUSA® Excel 36 kHz Disposable Wrench
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C5602
In Commercial Distribution

  • 30381780026116 ()
  • 10381780026112 ()
  • M269C56021 ()

  • 36kHz frequency
C5602

  • Ultrasonic surgical system torque wrench, single-use
CUSA® Excel 23 kHz Disposable Wrench
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C5601
In Commercial Distribution

  • 30381780026109 ()
  • 10381780026105 ()
  • M269C56011 ()

  • 23 kHz frequency
C5601

  • Ultrasonic surgical system torque wrench, single-use
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