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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.
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
Apex Locator, Mark VII™
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
017-23180
Not in Commercial Distribution

  • H834017231800 ()
  • 10381780510437 ()
017-23180

  • Endodontic apex locator
JUMPSTART, 4.0" DIA, HELIX COMP. LAYER
ARTHREX, INC.
HRD4IN-10
In Commercial Distribution

  • 00888867187146 ()
  • M150HRD4IN100 ()
  • 10888867187143 ()
HRD4IN-10

  • Exudate-absorbent dressing, non-gel, antimicrobial
JUMPSTART, 3.0" DIA, HELIX COMP. LAYER
ARTHREX, INC.
HRD3IN-10
In Commercial Distribution

  • 00888867187139 ()
  • M150HRD3IN100 ()
  • 10888867187136 ()
HRD3IN-10

  • Exudate-absorbent dressing, non-gel, antimicrobial
JUMPSTART, 2.5" DIA., HELIX COMP. LAYER
ARTHREX, INC.
HRD25IN-10
In Commercial Distribution

  • 00888867187122 ()
  • M150HRD25IN100 ()
  • 10888867187129 ()
HRD25IN-10

  • Exudate-absorbent dressing, non-gel, antimicrobial
JUMPSTART, 4.5" X 10", HELIX COMP. LAYER
ARTHREX, INC.
HR4510-05
In Commercial Distribution

  • 00888867186972 ()
  • M150HR4510050 ()
  • 10888867186979 ()
HR4510-05

  • Exudate-absorbent dressing, non-gel, antimicrobial
JUMPSTART, 1" X 1", SINGLE LAYER
ARTHREX, INC.
R0101F-10
In Commercial Distribution

  • 00888867186736 ()
  • M150R0101F100 ()
  • 10888867186733 ()
R0101F-10

  • Exudate-absorbent dressing, non-gel, antimicrobial
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