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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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CEMENTSYS KPT1505-CDS FF XPDR 15/3 1 STP
MEDTRONIC SOFAMOR DANEK, INC.
KPT1505-CDS
In Commercial Distribution

  • 00643169100589 ()


  • Balloon kyphoplasty kit
KIT KPT2001 KYPHOPAK TRAY 20/3 FF W/ITK
MEDTRONIC SOFAMOR DANEK, INC.
KPT2001
In Commercial Distribution

  • 00643169100572 ()


  • Instrument tray, reusable
CEMENTSYS KPT2002-CDS OIS XPDR 20/3
MEDTRONIC SOFAMOR DANEK, INC.
KPT2002-CDS
In Commercial Distribution

  • 00643169100565 ()


  • Balloon kyphoplasty kit
CEMENTSYS KPT2003-CDS AOIS XPDR 20/3
MEDTRONIC SOFAMOR DANEK, INC.
KPT2003-CDS
Not in Commercial Distribution

  • 00643169100558 ()


  • Balloon kyphoplasty kit
CEMENTSYS KPT2005-CDS FF XPDR 20/3 1 STP
MEDTRONIC SOFAMOR DANEK, INC.
KPT2005-CDS
In Commercial Distribution

  • 00643169100541 ()


  • Balloon kyphoplasty kit
STARTER EX1011136 T-27 NON B/O PLUG
MEDTRONIC SOFAMOR DANEK, INC.
EX1011136
In Commercial Distribution

  • 00643169100381 ()


  • Orthopaedic instrument surgical connector
70MM SEQ REDUCER X1111035 4.75 MAS
MEDTRONIC SOFAMOR DANEK, INC.
X1111035
In Commercial Distribution

  • 00643169100350 ()


  • Orthopaedic rod reducer
INSTRUMENT KIT PFF0001 FACET FIXATION
MEDTRONIC SOFAMOR DANEK, INC.
PFF0001
In Commercial Distribution

  • 00643169099432 ()


  • Neurosurgical curette, single-use
SCREW PFF0040 40MM FACET FIXATION ANCHOR
MEDTRONIC SOFAMOR DANEK, INC.
PFF0040
In Commercial Distribution

  • 00643169099425 ()

  • Outer Diameter: 40.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW PFF0035 35MM FACET FIXATION ANCHOR
MEDTRONIC SOFAMOR DANEK, INC.
PFF0035
In Commercial Distribution

  • 00643169099418 ()

  • Outer Diameter: 35.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW PFF0030 30MM FACET FIXATION ANCHOR
MEDTRONIC SOFAMOR DANEK, INC.
PFF0030
In Commercial Distribution

  • 00643169099401 ()

  • Outer Diameter: 30.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW PFF0025 25MM FACET FIXATION ANCHOR
MEDTRONIC SOFAMOR DANEK, INC.
PFF0025
In Commercial Distribution

  • 00643169099395 ()

  • Outer Diameter: 25.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
CONNECTOR 7753919 CLOSED LATERAL 19MM
MEDTRONIC SOFAMOR DANEK, INC.
7753919
In Commercial Distribution

  • 00643169098305 ()

  • Length: 19.0 Millimeter


  • Bone-screw internal spinal fixation system connector
TRANSLATOR EX1011022 HINGED FOR 6.35
MEDTRONIC SOFAMOR DANEK, INC.
EX1011022
In Commercial Distribution

  • 00643169097995 ()


  • Orthopaedic fixation implant alignment tool
TRANSLATOR EX1011021 HINGED FOR 5.5
MEDTRONIC SOFAMOR DANEK, INC.
EX1011021
In Commercial Distribution

  • 00643169097988 ()


  • Orthopaedic fixation implant alignment tool
HANDLE EX1011061 FLEX AWL
MEDTRONIC SOFAMOR DANEK, INC.
EX1011061
In Commercial Distribution

  • 00643169097964 ()


  • Surgical instrument handle, non-torque-limiting
AWL EX1011060 FLEXIBLE
MEDTRONIC SOFAMOR DANEK, INC.
EX1011060
In Commercial Distribution

  • 00643169097957 ()


  • Bone awl, reusable
MIXER A07A CEMENT
MEDTRONIC SOFAMOR DANEK, INC.
A07A
In Commercial Distribution

  • 00643169097889 ()


  • Manual orthopaedic cement mixer, reusable
BONE CEMENT C01A HV-R US
MEDTRONIC SOFAMOR DANEK, INC.
C01A
In Commercial Distribution

  • 00643169097865 ()


  • Orthopaedic cement, non-antimicrobial
BONE CEMENT C01B HV-R WITH MIXER US
MEDTRONIC SOFAMOR DANEK, INC.
C01B
In Commercial Distribution

  • 00643169097834 ()


  • Orthopaedic cement, non-antimicrobial
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