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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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KYPHON® EXPRESS™ Osteo Introducer® System - 00643169102996

DRILL T24A EXPRESS
MEDTRONIC SOFAMOR DANEK, INC.
T24A
In Commercial Distribution

  • 00643169102996 ()


  • Bone access channel kit

KyphoPak™ Tray - 00643169102989

KIT KPT2005 KYPAK TRY 20/3 FF W/ONE STEP
MEDTRONIC SOFAMOR DANEK, INC.
KPT2005
Not in Commercial Distribution

  • 00643169102989 ()


  • Balloon kyphoplasty kit

KyphoPak™ Tray - 00643169102972

KIT KPT2004 KYPAK TRY 20/3 ADDL FRACTURE
MEDTRONIC SOFAMOR DANEK, INC.
KPT2004
Not in Commercial Distribution

  • 00643169102972 ()


  • Instrument tray, reusable

KyphoPak™ Tray - 00643169102965

KIT KPT2003 KYPAK TRY 20/3 FF W/ADV OIS
MEDTRONIC SOFAMOR DANEK, INC.
KPT2003
Not in Commercial Distribution

  • 00643169102965 ()


  • Balloon kyphoplasty kit

KyphoPak™ Tray - 00643169102958

KIT KPT2002 KYPAK TRY 20/3 FF W/OIS
MEDTRONIC SOFAMOR DANEK, INC.
KPT2002
In Commercial Distribution

  • 00643169102958 ()


  • Instrument tray, reusable

KyphoPak™ Tray - 00643169102941

KIT KPT1505 KYPAK TRY 15/3 FF W/ONESTEP
MEDTRONIC SOFAMOR DANEK, INC.
KPT1505
In Commercial Distribution

  • 00643169102941 ()


  • Balloon kyphoplasty kit

KyphoPak™ Tray - 00643169102934

KIT KPT1504 KYPAK TRY 15/3 ADDL FRACTURE
MEDTRONIC SOFAMOR DANEK, INC.
KPT1504
Not in Commercial Distribution

  • 00643169102934 ()


  • Instrument tray, reusable

KyphoPak™ Tray - 00643169102927

KIT KPT1503 KYPAK TRY 15/3 FF W/ADV OIS
MEDTRONIC SOFAMOR DANEK, INC.
KPT1503
In Commercial Distribution

  • 00643169102927 ()


  • Balloon kyphoplasty kit

KyphoPak™ Tray - 00643169102910

KIT KPT1502 KYPAK TRY 15/3 FF W/OIS
MEDTRONIC SOFAMOR DANEK, INC.
KPT1502
In Commercial Distribution

  • 00643169102910 ()


  • Balloon kyphoplasty kit

KyphoPak™ Tray - 00643169102903

KIT KPT1004 KYPAK TRY 10/3 ADDL FRACTURE
MEDTRONIC SOFAMOR DANEK, INC.
KPT1004
Not in Commercial Distribution

  • 00643169102903 ()


  • Instrument tray, reusable

N/A - 00643169102569

TRIAL KIT 9734947 CAPSTONE 8x26mm
MEDTRONIC NAVIGATION, INC.
9734947
In Commercial Distribution

  • 00643169102569 ()


  • Spinal implant trial

Medtronic Reusable Instruments - 00643169102538

OSTEOTOME X1111047 ANGLED
MEDTRONIC SOFAMOR DANEK, INC.
X1111047
In Commercial Distribution

  • 00643169102538 ()


  • Orthopaedic osteotome

Medtronic Reusable Instruments - 00643169102521

OSTEOTOME X1111046 STRAIGHT
MEDTRONIC SOFAMOR DANEK, INC.
X1111046
In Commercial Distribution

  • 00643169102521 ()


  • Orthopaedic osteotome

Quadcut® - 00643169101999

BLADE 1883480HRE QUADCUT 3.4MM X 13CM
MEDTRONIC XOMED, INC.
1883480HRE
In Commercial Distribution

  • 00643169101999 ()

  • Outer Diameter: 3.4 Millimeter


  • Surgical saw blade, oscillating, single-use

Quadcut® - 00643169101982

BLADE 1883080HRE QUADCUT 3.0MM X 13CM
MEDTRONIC XOMED, INC.
1883080HRE
In Commercial Distribution

  • 00643169101982 ()

  • Outer Diameter: 3.0 Millimeter


  • Surgical saw blade, oscillating, single-use

NavLock - 00643169101968

TRACKER 9734734 NavLock UNIVERSAL GREEN
MEDTRONIC NAVIGATION, INC.
9734734
In Commercial Distribution

  • 00643169101968 ()


  • Multi-purpose stereotactic surgery system

Medtronic Reusable Instruments - 00643169101869

PITUITARY X1111003 4MM UPBITING
MEDTRONIC SOFAMOR DANEK, INC.
X1111003
In Commercial Distribution

  • 00643169101869 ()


  • Orthopaedic joint/limb rongeur

Medtronic Reusable Instruments - 00643169101852

PITUITARY X1111002 4MM STRAIGHT
MEDTRONIC SOFAMOR DANEK, INC.
X1111002
In Commercial Distribution

  • 00643169101852 ()


  • Orthopaedic joint/limb rongeur

VERTEX® Reconstruction System - 00643169101463

ROD G7753870 PRE-CUT 3.5MM X 70MM CCM
MEDTRONIC SOFAMOR DANEK, INC.
G7753870
In Commercial Distribution

  • 00643169101463 ()

  • 3.5mm x 70mm


  • Spinal bone screw, non-bioabsorbable

VERTEX® Reconstruction System - 00643169101371

ROD G7753880 PRE-CUT 3.5MM X 80MM CCM
MEDTRONIC SOFAMOR DANEK, INC.
G7753880
In Commercial Distribution

  • 00643169101371 ()

  • 3.5mm x 80mm


  • Spinal bone screw, non-bioabsorbable

VERTEX® Reconstruction System - 00643169101357

ROD G7753890 PRE-CUT 3.5MM X 90MM CCM
MEDTRONIC SOFAMOR DANEK, INC.
G7753890
In Commercial Distribution

  • 00643169101357 ()

  • 3.5mm x 90mm


  • Spinal bone screw, non-bioabsorbable

VERTEX® Reconstruction System - 00643169101333

ROD G7753900 PRE-CUT 3.5MM X 100MM CCM
MEDTRONIC SOFAMOR DANEK, INC.
G7753900
In Commercial Distribution

  • 00643169101333 ()

  • 3.5mm x 100mm


  • Spinal bone screw, non-bioabsorbable

Medtronic Reusable Instruments - 00643169101265

CURETTE EX1011211 REV. PULL 1.8MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1011211
In Commercial Distribution

  • 00643169101265 ()


  • Bone curette, reusable

Medtronic Reusable Instruments - 00643169101258

CURETTE EX1011210 REV. STRAIGHT 1.8MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1011210
In Commercial Distribution

  • 00643169101258 ()


  • Bone curette, reusable

Medtronic Reusable Instruments - 00643169101241

CURETTE EX1011155 REV. PULL 5.2MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1011155
In Commercial Distribution

  • 00643169101241 ()


  • Bone curette, reusable

KYPHON® Cement Delivery System - 00643169100756

CEMENT CARTRIDGES CC02A CDS
MEDTRONIC SOFAMOR DANEK, INC.
CC02A
In Commercial Distribution

  • 00643169100756 ()


  • Orthopaedic cement dispenser

Medtronic Reusable Instruments - 00643169100749

CEMENT GUN AND BONE FILLER CDS2A SISE 2
MEDTRONIC SOFAMOR DANEK, INC.
CDS2A
In Commercial Distribution

  • 00643169100749 ()


  • Orthopaedic cement dispenser

Medtronic Reusable Instruments - 00643169100725

CEMENT GUN AND BONE FILLER CDS3A SIZE 3
MEDTRONIC SOFAMOR DANEK, INC.
CDS3A
In Commercial Distribution

  • 00643169100725 ()


  • Orthopaedic cement dispenser

KyphoPak™ Express™ Tray - 00643169100701

CEMENTSYS KPE1001-CDS FF EXPRESS 10/2
MEDTRONIC SOFAMOR DANEK, INC.
KPE1001-CDS
In Commercial Distribution

  • 00643169100701 ()


  • Balloon kyphoplasty kit

KyphoPak™ Express™ Tray - 00643169100695

KIT KPE1003 KYPAK EXP TRY 15/2 FF W/EOIS
MEDTRONIC SOFAMOR DANEK, INC.
KPE1003
In Commercial Distribution

  • 00643169100695 ()


  • Balloon kyphoplasty kit
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