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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COUNTER TORQ W/ QC-20MM
MEDTRONIC SOFAMOR DANEK, INC.
X0602014
In Commercial Distribution

  • 00721902535277 ()


  • Orthopaedic counter-torque/rod-pushing instrument
ADJUSTABLE DRILL BIT NON-STER
MEDTRONIC SOFAMOR DANEK, INC.
X0602455
In Commercial Distribution

  • 00721902525636 ()


  • Fluted surgical drill bit, reusable
SADDLE INSERTER
MEDTRONIC SOFAMOR DANEK, INC.
X0402008
In Commercial Distribution

  • 00721902507571 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
LONG 3D NITINOL SCREW EXTENDER
MEDTRONIC SOFAMOR DANEK, INC.
X0502012
In Commercial Distribution

  • 00721902485893 ()


  • General internal orthopaedic fixation system implantation kit
90 DEGREE ANGLED AWL
MEDTRONIC SOFAMOR DANEK, INC.
X0502007
In Commercial Distribution

  • 00721902485886 ()


  • Bone awl, reusable
PEDICLE FINDER NEUBARTD
MEDTRONIC SOFAMOR DANEK, INC.
X0502008
In Commercial Distribution

  • 00721902481505 ()


  • Spinal bone screw, non-bioabsorbable
3.5MM X 14MM CANCELLOUS TAP
MEDTRONIC SOFAMOR DANEK, INC.
X0502006
In Commercial Distribution

  • 00721902481499 ()


  • Bone tap, reusable
INSTRUMENT 2900154 10MM CURETTE
MEDTRONIC SOFAMOR DANEK, INC.
2900154
In Commercial Distribution

  • 00721902454653 ()


  • Bone curette, reusable
BONE CUTTER 853-620
MEDTRONIC SOFAMOR DANEK, INC.
853-620
In Commercial Distribution

  • 00721902451270 ()


  • Orthopaedic knife
CDH SHORT THREAD 5.5MM TAP
MEDTRONIC SOFAMOR DANEK, INC.
X0401055
In Commercial Distribution

  • 00721902445989 ()


  • Bone tap, reusable
CDH SHORT THREAD 4.5MM TAP
MEDTRONIC SOFAMOR DANEK, INC.
X0401045
In Commercial Distribution

  • 00721902445965 ()


  • Bone tap, reusable
ADJUSTABLE CORTICAL DRILL BIT
MEDTRONIC SOFAMOR DANEK, INC.
X1201027
In Commercial Distribution

  • 00721902440939 ()


  • Surgical drill guide, reusable
ADJUSTABLE CANC DRILL BIT
MEDTRONIC SOFAMOR DANEK, INC.
X1201026
In Commercial Distribution

  • 00721902440922 ()


  • Fluted surgical drill bit, reusable
14MM CANC DRILL BIT
MEDTRONIC SOFAMOR DANEK, INC.
X1201025
In Commercial Distribution

  • 00721902440915 ()


  • Surgical drill guide, reusable
VERTEX SHORT DRILL GUIDE
MEDTRONIC SOFAMOR DANEK, INC.
X1201022
In Commercial Distribution

  • 00721902439131 ()


  • Surgical drill guide, reusable
12MM/8MM DISTRACTOR
MEDTRONIC SOFAMOR DANEK, INC.
YIB1299-102
Not in Commercial Distribution

  • 00721902436024 ()


  • Orthopaedic surgical distractor, internal
14MM/10MM DISTRACTOR
MEDTRONIC SOFAMOR DANEK, INC.
YIB0300-38
Not in Commercial Distribution

  • 00721902435973 ()


  • Orthopaedic surgical distractor, internal
16MM INSERTER
MEDTRONIC SOFAMOR DANEK, INC.
YIB0200-009
Not in Commercial Distribution

  • 00721902435959 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
PYRAMESH LARGE OVOID TRAY BASE
MEDTRONIC SOFAMOR DANEK, INC.
9050891
In Commercial Distribution

  • 00721902383922 ()


  • Instrument tray, reusable
FLAT HANDLE STRAIGHT PROBE
MEDTRONIC SOFAMOR DANEK, INC.
X1201012
In Commercial Distribution

  • 00721902354823 ()


  • Surgical instrument handle, non-torque-limiting
EXT NERVE ROOT RETRACTOR
MEDTRONIC SOFAMOR DANEK, INC.
X1201555
In Commercial Distribution

  • 00721902354656 ()


  • Surgical retractor/retraction system blade, reusable
BLADE HOLDER
MEDTRONIC SOFAMOR DANEK, INC.
X0102001
In Commercial Distribution

  • 00721902342660 ()


  • Orthopaedic knife
OSTEOTOME X0102009 STRAIGHT GREY 1/2
MEDTRONIC SOFAMOR DANEK, INC.
X0102009
In Commercial Distribution

  • 00721902342141 ()


  • Orthopaedic osteotome
10MM CURETTE
MEDTRONIC SOFAMOR DANEK, INC.
YIB0801-069
Not in Commercial Distribution

  • 00721902342042 ()


  • Bone curette, reusable
CORNERSTONE TAMP W/ DEPTH STOP
MEDTRONIC SOFAMOR DANEK, INC.
X0102008
In Commercial Distribution

  • 00721902341977 ()


  • Surgical tamp, reusable
TEMPLATE X8081572 NITINOL ROD 8 INCH
MEDTRONIC SOFAMOR DANEK, INC.
X8081572
In Commercial Distribution

  • 00721902341946 ()


  • Surgical implant template, reusable
STRAIGHT PITUITARY
MEDTRONIC SOFAMOR DANEK, INC.
YIB1001-013
In Commercial Distribution

  • 00721902341168 ()


  • Orthopaedic joint/limb rongeur
DRIVER X1201019 EXTENDED 4 INCH 3D
MEDTRONIC SOFAMOR DANEK, INC.
X1201019
In Commercial Distribution

  • 00721902340789 ()


  • Orthopaedic implant driver
EXTENDED 6.5 TAP
MEDTRONIC SOFAMOR DANEK, INC.
X1201016
In Commercial Distribution

  • 00721902340765 ()


  • Bone tap, reusable
CURRETTE X0102627 METRX 1.8MM ANGLED
MEDTRONIC SOFAMOR DANEK, INC.
X0102627
In Commercial Distribution

  • 00721902337147 ()


  • Bone curette, reusable
EXT. 3D SCRWDRVR W/ EGG HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X1201008
In Commercial Distribution

  • 00721902336959 ()


  • Surgical instrument handle, non-torque-limiting
12 X 12 DEG SPREADER
MEDTRONIC SOFAMOR DANEK, INC.
YIB0801-034
In Commercial Distribution

  • 00721902336812 ()


  • Bone distraction forceps
6MM SPREADER
MEDTRONIC SOFAMOR DANEK, INC.
YIB0801-031
In Commercial Distribution

  • 00721902336782 ()


  • Bone distraction forceps
SPECIAL BOOT CURETTE
MEDTRONIC SOFAMOR DANEK, INC.
YIB0801-050
Not in Commercial Distribution

  • 00721902336669 ()


  • Bone curette, reusable
SPECIAL DUAL ENDED BONE PUNCH
MEDTRONIC SOFAMOR DANEK, INC.
YIB0801-046
In Commercial Distribution

  • 00721902336546 ()


  • Bone-coring punch, reusable
OUTRIGGER DISTRACTOR
MEDTRONIC SOFAMOR DANEK, INC.
X1101012
In Commercial Distribution

  • 00721902332722 ()


  • Orthopaedic surgical distractor, internal
EXT. 3D STRAIGHT PROBE
MEDTRONIC SOFAMOR DANEK, INC.
X0102003
In Commercial Distribution

  • 00721902332098 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
EXT. 3D CURVED PROBE
MEDTRONIC SOFAMOR DANEK, INC.
X0102002
In Commercial Distribution

  • 00721902332081 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
OBLIQUE HOUSING 16 / 26
MEDTRONIC SOFAMOR DANEK, INC.
YIB1201-014
Not in Commercial Distribution

  • 00721902331664 ()


  • Orthopaedic surgical distractor, internal
OBLIQUE HOUSING 12 / 26
MEDTRONIC SOFAMOR DANEK, INC.
YIB1201-012
Not in Commercial Distribution

  • 00721902331640 ()


  • Orthopaedic surgical distractor, internal
INSTRUMENT 9166050 STRGHT IMPLANT HOLDER
MEDTRONIC SOFAMOR DANEK, INC.
9166050
In Commercial Distribution

  • 00721902331169 ()


  • Surgical implant/trial-implant/sizer holder, reusable
SHAVER YIB0801-045 11/14MM 6 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
YIB0801-045
Not in Commercial Distribution

  • 00721902330414 ()


  • Orthopaedic knife
SHAVER YIB0801-0423 9/12MM 6 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
YIB0801-043
Not in Commercial Distribution

  • 00721902330377 ()


  • Orthopaedic knife
SHAVER YIB0801-042 8/11MM 6 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
YIB0801-042
Not in Commercial Distribution

  • 00721902330360 ()


  • Orthopaedic knife
SHAVER YIB0801-041 7/10MM 6 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
YIB0801-041
Not in Commercial Distribution

  • 00721902330353 ()


  • Orthopaedic knife
3.75MM SOLID TAP
MEDTRONIC SOFAMOR DANEK, INC.
X8683701
In Commercial Distribution

  • 00721902329821 ()


  • Bone tap, reusable
INSTRUMENT 9560731 22MMX4CM TUBLR RTRCTR
MEDTRONIC SOFAMOR DANEK, INC.
9560731
In Commercial Distribution

  • 00721902316982 ()


  • Surgical retractor/retraction system blade, reusable
60MM FIXED TL BLADE W/4 TEETH
MEDTRONIC SOFAMOR DANEK, INC.
X1101260
In Commercial Distribution

  • 00721902303029 ()


  • Orthopaedic knife
55MM FIXED TL BLADE W/4 TEETH
MEDTRONIC SOFAMOR DANEK, INC.
X1101255
In Commercial Distribution

  • 00721902302978 ()


  • Orthopaedic knife
50MM FIXED TL BLADE W/4 TEETH
MEDTRONIC SOFAMOR DANEK, INC.
X1101250
In Commercial Distribution

  • 00721902302954 ()


  • Orthopaedic knife
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