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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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KyphoPak™ Express™ Tray - 00643169100688

CEMENTSYS KPE1003-CDS FF EXPRESS 15/2
MEDTRONIC SOFAMOR DANEK, INC.
KPE1003-CDS
In Commercial Distribution

  • 00643169100688 ()


  • Balloon kyphoplasty kit

KyphoPak™ Tray - 00643169100671

KIT KPT1001 KYPHOPAK TRAY 10/3 FF W/ITK
MEDTRONIC SOFAMOR DANEK, INC.
KPT1001
Not in Commercial Distribution

  • 00643169100671 ()


  • Instrument tray, reusable

KyphoPak™ Tray - 00643169100664

KIT KPT1002 KYPHOPAK TRAY 10/3 FF W/OIS
MEDTRONIC SOFAMOR DANEK, INC.
KPT1002
In Commercial Distribution

  • 00643169100664 ()


  • Balloon kyphoplasty kit

KyphoPak™ Tray - 00643169100657

CEMENTSYS KPT1002-CDS OIS XPDR 10/3
MEDTRONIC SOFAMOR DANEK, INC.
KPT1002-CDS
Not in Commercial Distribution

  • 00643169100657 ()


  • Balloon kyphoplasty kit

KyphoPak™ Tray - 00643169100640

CEMENTSYS KPT1003-CDS AOIS XPDR 10/3
MEDTRONIC SOFAMOR DANEK, INC.
KPT1003-CDS
Not in Commercial Distribution

  • 00643169100640 ()


  • Balloon kyphoplasty kit

KyphoPak™ Tray - 00643169100633

KIT KPT1005 KYPAK TRY 10/3 FF W/ONESTEP
MEDTRONIC SOFAMOR DANEK, INC.
KPT1005
Not in Commercial Distribution

  • 00643169100633 ()


  • Balloon kyphoplasty kit

KyphoPak™ Tray - 00643169100626

CEMENTSYS KPT1005-CDS FF XPDR 10/3 1 STP
MEDTRONIC SOFAMOR DANEK, INC.
KPT1005-CDS
In Commercial Distribution

  • 00643169100626 ()


  • Balloon kyphoplasty kit

KyphoPak™ Tray - 00643169100619

KIT KPT1501 KYPHOPAK TRAY 15/3 FF W/ITK
MEDTRONIC SOFAMOR DANEK, INC.
KPT1501
In Commercial Distribution

  • 00643169100619 ()


  • Instrument tray, reusable

KyphoPak™ Tray - 00643169100602

CEMENTSYS KPT1502-CDS OIS XPDR 15/3
MEDTRONIC SOFAMOR DANEK, INC.
KPT1502-CDS
In Commercial Distribution

  • 00643169100602 ()


  • Balloon kyphoplasty kit

KyphoPak™ Tray - 00643169100596

CEMENTSYS KPT1503-CDS AOIS XPDR 15/3
MEDTRONIC SOFAMOR DANEK, INC.
KPT1503-CDS
Not in Commercial Distribution

  • 00643169100596 ()


  • Balloon kyphoplasty kit

KyphoPak™ Tray - 00643169100589

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

  • 00643169100589 ()


  • Balloon kyphoplasty kit

KyphoPak™ Tray - 00643169100572

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

  • 00643169100572 ()


  • Instrument tray, reusable

KyphoPak™ Tray - 00643169100565

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

  • 00643169100565 ()


  • Balloon kyphoplasty kit

KyphoPak™ Tray - 00643169100558

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

  • 00643169100558 ()


  • Balloon kyphoplasty kit

KyphoPak™ Tray - 00643169100541

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

  • 00643169100541 ()


  • Balloon kyphoplasty kit

Medtronic Reusable Instruments - 00643169100381

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

  • 00643169100381 ()


  • Orthopaedic instrument surgical connector

Medtronic Reusable Instruments - 00643169100350

70MM SEQ REDUCER X1111035 4.75 MAS
MEDTRONIC SOFAMOR DANEK, INC.
X1111035
In Commercial Distribution

  • 00643169100350 ()


  • Orthopaedic rod reducer

MEDTRONIC Facet Screw Instruments - 00643169099432

INSTRUMENT KIT PFF0001 FACET FIXATION
MEDTRONIC SOFAMOR DANEK, INC.
PFF0001
In Commercial Distribution

  • 00643169099432 ()


  • Neurosurgical curette, single-use

ANCHOR FS™ Facet Fixation System - 00643169099425

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

ANCHOR FS™ Facet Fixation System - 00643169099418

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

ANCHOR FS™ Facet Fixation System - 00643169099401

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

ANCHOR FS™ Facet Fixation System - 00643169099395

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

VERTEX® Reconstruction System - 00643169098305

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

Medtronic Reusable Instruments - 00643169097995

TRANSLATOR EX1011022 HINGED FOR 6.35
MEDTRONIC SOFAMOR DANEK, INC.
EX1011022
In Commercial Distribution

  • 00643169097995 ()


  • Orthopaedic fixation implant alignment tool

Medtronic Reusable Instruments - 00643169097988

TRANSLATOR EX1011021 HINGED FOR 5.5
MEDTRONIC SOFAMOR DANEK, INC.
EX1011021
In Commercial Distribution

  • 00643169097988 ()


  • Orthopaedic fixation implant alignment tool

Medtronic Reusable Instruments - 00643169097964

HANDLE EX1011061 FLEX AWL
MEDTRONIC SOFAMOR DANEK, INC.
EX1011061
In Commercial Distribution

  • 00643169097964 ()


  • Surgical instrument handle, non-torque-limiting

Medtronic Reusable Instruments - 00643169097957

AWL EX1011060 FLEXIBLE
MEDTRONIC SOFAMOR DANEK, INC.
EX1011060
In Commercial Distribution

  • 00643169097957 ()


  • Bone awl, reusable

N/A - 00643169097889

MIXER A07A CEMENT
MEDTRONIC SOFAMOR DANEK, INC.
A07A
In Commercial Distribution

  • 00643169097889 ()


  • Manual orthopaedic cement mixer, reusable

KYPHON® HV-R® Bone Cement - 00643169097865

BONE CEMENT C01A HV-R US
MEDTRONIC SOFAMOR DANEK, INC.
C01A
In Commercial Distribution

  • 00643169097865 ()


  • Orthopaedic cement, non-antimicrobial

KYPHON® HV-R® Bone Cement and KYPHON® Mixer Pack - 00643169097834

BONE CEMENT C01B HV-R WITH MIXER US
MEDTRONIC SOFAMOR DANEK, INC.
C01B
In Commercial Distribution

  • 00643169097834 ()


  • Orthopaedic cement, non-antimicrobial

ActivOs™ 10 Bone Cement - 00643169097810

BONE CEMENT C10A KYPHON ACTIVOS 10
MEDTRONIC SOFAMOR DANEK, INC.
C10A
In Commercial Distribution

  • 00643169097810 ()


  • Orthopaedic cement, non-antimicrobial

KYPHON® Xpede™ Bone Cement - 00643169097803

BONE CEMENT CX01A XPEDE US
MEDTRONIC SOFAMOR DANEK, INC.
CX01A
In Commercial Distribution

  • 00643169097803 ()


  • Orthopaedic cement, non-antimicrobial

KYPHON® Xpede™ Bone Cement and KYPHON® Mixer Pack - 00643169097797

BONE CEMENT CX01B XPEDE W MIXER US
MEDTRONIC SOFAMOR DANEK, INC.
CX01B
In Commercial Distribution

  • 00643169097797 ()


  • Orthopaedic cement, non-antimicrobial

COLLIN - 05056100711808

COLLIN - Epistaxis Pack, drawstring, multi-layered - 10.0cm x10 PCS
NETWORK MEDICAL PRODUCTS LIMITED
10141L
In Commercial Distribution

  • 05056100711808 ()


  • Intranasal splint, non-biodegradable

CD HORIZON® Spinal System - 00643169091719

CROSSLINK X0811498 LP TI 5.5/6.35 50MM
MEDTRONIC SOFAMOR DANEK, INC.
X0811498
In Commercial Distribution

  • 00643169091719 ()

  • Length: 50.0 Millimeter


  • Bone-screw internal spinal fixation system connector

CD HORIZON® Spinal System - 00643169091702

CROSSLINK X0811497 LP TI 5.5/6.35 45MM
MEDTRONIC SOFAMOR DANEK, INC.
X0811497
In Commercial Distribution

  • 00643169091702 ()

  • Length: 45.0 Millimeter


  • Bone-screw internal spinal fixation system connector

CD HORIZON® Spinal System - 00643169091689

CROSSLINK X0811495 LP TI 5.5/6.35 37MM
MEDTRONIC SOFAMOR DANEK, INC.
X0811495
In Commercial Distribution

  • 00643169091689 ()

  • Length: 37.0 Millimeter


  • Bone-screw internal spinal fixation system connector

CD HORIZON® Spinal System - 00643169091665

CROSSLINK X0811493 LP TI 5.5/6.35 34MM
MEDTRONIC SOFAMOR DANEK, INC.
X0811493
In Commercial Distribution

  • 00643169091665 ()

  • Length: 34.0 Millimeter


  • Bone-screw internal spinal fixation system connector

CD HORIZON® Spinal System - 00643169091603

CROSSLINK X0811487 LP TI 5.5/6.35 25MM
MEDTRONIC SOFAMOR DANEK, INC.
X0811487
In Commercial Distribution

  • 00643169091603 ()

  • Length: 25.0 Millimeter


  • Bone-screw internal spinal fixation system connector

CD HORIZON® Spinal System - 00643169091580

CROSSLINK X0811485 LP TI 5.5/6.35 22MM
MEDTRONIC SOFAMOR DANEK, INC.
X0811485
In Commercial Distribution

  • 00643169091580 ()

  • Length: 22.0 Millimeter


  • Bone-screw internal spinal fixation system connector

CD HORIZON® Spinal System - 00643169091566

CROSSLINK X0811483 LP TI 5.5/6.35 19MM
MEDTRONIC SOFAMOR DANEK, INC.
X0811483
In Commercial Distribution

  • 00643169091566 ()

  • Length: 19.0 Millimeter


  • Bone-screw internal spinal fixation system connector

CD HORIZON® Spinal System - 00643169091542

CROSSLINK X0811481 LP TI 5.5/6.35 16MM
MEDTRONIC SOFAMOR DANEK, INC.
X0811481
In Commercial Distribution

  • 00643169091542 ()

  • Length: 16.0 Millimeter


  • Bone-screw internal spinal fixation system connector

N/A - 00643169091498

ADJUSTER 3990057 CAPSTONE IR ADJ ONE
MEDTRONIC SOFAMOR DANEK, INC.
3990057
In Commercial Distribution

  • 00643169091498 ()


  • Orthopaedic implant impactor, reusable

N/A - 00643169091467

T HANDLE 3990060 LARGE
MEDTRONIC SOFAMOR DANEK, INC.
3990060
In Commercial Distribution

  • 00643169091467 ()


  • Surgical instrument handle, non-torque-limiting

Medtronic Reusable Instruments - 00643169091443

SHAFT 3990002 LONG THREADED
MEDTRONIC SOFAMOR DANEK, INC.
3990002
In Commercial Distribution

  • 00643169091443 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

CD HORIZON® Spinal System - 00643169090590

XLNK X0911126 X10 FIXED 4.76 SS 60MM
MEDTRONIC SOFAMOR DANEK, INC.
X0911126
In Commercial Distribution

  • 00643169090590 ()

  • Length: 60.0 Millimeter


  • Bone-screw internal spinal fixation system connector

CD HORIZON® Spinal System - 00643169090583

XLNK X0911125 X10 FIXED 4.76 SS 55MM
MEDTRONIC SOFAMOR DANEK, INC.
X0911125
In Commercial Distribution

  • 00643169090583 ()

  • Length: 55.0 Millimeter


  • Bone-screw internal spinal fixation system connector

CD HORIZON® Spinal System - 00643169090569

XLNK X0911123 X10 FIXED 4.76 SS 45MM
MEDTRONIC SOFAMOR DANEK, INC.
X0911123
In Commercial Distribution

  • 00643169090569 ()

  • Length: 45.0 Millimeter


  • Bone-screw internal spinal fixation system connector

Collin - 05056100702868

Collin Epistaxis Pack Short 5.5cm - Carton
NETWORK MEDICAL PRODUCTS LIMITED
10150C
Not in Commercial Distribution

  • 05056100702868 ()
  • 05056100702875 ()


  • Intranasal splint, non-biodegradable

CD HORIZON® Spinal System - 00643169090545

XLNK X0911121 X10 FIXED 4.76 SS 37MM
MEDTRONIC SOFAMOR DANEK, INC.
X0911121
In Commercial Distribution

  • 00643169090545 ()

  • Length: 37.0 Millimeter


  • Bone-screw internal spinal fixation system connector
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