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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® Selector® 35KHz Ultrafine MicroTip Set
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523078
Not in Commercial Distribution

  • M27315230781 ()
  • 10381780040606 ()
  • 00381780040609 ()

  • 35kHz Ultrasonic Frequency
1523078

  • Soft-tissue ultrasonic surgical system handpiece tip, reusable
CUSA® Selector® 24KHz Ultrafine MicroTip
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523067
Not in Commercial Distribution

  • M27315230671 ()
  • 10381780040590 ()
  • 00381780040593 ()

  • 24kHz Ultrasonic Frequency
1523067

  • Soft-tissue ultrasonic surgical system handpiece tip, reusable
CUSA® Selector® 35KHz Ultrafine MicroTip
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523077
Not in Commercial Distribution

  • M27315230771 ()
  • 10381780040583 ()

  • 35kHz Ultrasonic Frequency
1523077

  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
CUSA® Selector® 24kHz Laparascopic Flue (Pack of 10)
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523032
Not in Commercial Distribution

  • M27315230321 ()
  • 10381780040682 ()
  • 00381780040685 ()

  • 24kHz Ultrasonic Frequency
1523032

  • Ultrasonic surgical system flue
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