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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HEAD POSITIONER EX0217081 3.5MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0217081
In Commercial Distribution

  • 00643169986374 ()


  • Orthopaedic fixation implant alignment tool
DRILL GUIDE EX0217080 FIXED 20MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0217080
In Commercial Distribution

  • 00643169986367 ()


  • Surgical drill guide, reusable
REDUCER EX0217015 HS 5.5/6.0 EXTENDED
MEDTRONIC SOFAMOR DANEK, INC.
EX0217015
In Commercial Distribution

  • 00643169986206 ()


  • Orthopaedic rod reducer
EXTENDER EX0217014 CLOSD 5.5/6.0 EXTNDED
MEDTRONIC SOFAMOR DANEK, INC.
EX0217014
In Commercial Distribution

  • 00643169986190 ()


  • Orthopaedic rod reducer
TUBE EX0117046 OUTER ASSY 4.75MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0117046
In Commercial Distribution

  • 00643169984691 ()


  • Orthopaedic rod reducer
TUBE EX0117045 INNER ASSY 4.75MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0117045
In Commercial Distribution

  • 00643169984684 ()


  • Orthopaedic rod reducer
CURTTE X0217051 5.2MM RHT OFST FRWD ANGL
MEDTRONIC SOFAMOR DANEK, INC.
X0217051
In Commercial Distribution

  • 00643169984677 ()


  • Bone curette, reusable
CURTTE X0217050 5.2MM LFT OFST FRWD ANGL
MEDTRONIC SOFAMOR DANEK, INC.
X0217050
In Commercial Distribution

  • 00643169984660 ()


  • Bone curette, reusable
CURTTE X0217049 5.2MM RHT OFST RVRS ANGL
MEDTRONIC SOFAMOR DANEK, INC.
X0217049
In Commercial Distribution

  • 00643169984653 ()


  • Bone curette, reusable
CURTTE X0217048 5.2MM LFT OFST RVRS ANGL
MEDTRONIC SOFAMOR DANEK, INC.
X0217048
In Commercial Distribution

  • 00643169984646 ()


  • Bone curette, reusable
COBB EX0217074 18MM ANGLED LEFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0217074
In Commercial Distribution

  • 00643169983717 ()


  • Bone lever/elevator, reusable
COBB EX0217073 18MM ANGLED RIGHT
MEDTRONIC SOFAMOR DANEK, INC.
EX0217073
In Commercial Distribution

  • 00643169983700 ()


  • Bone lever/elevator, reusable
IMPACTOR EX0217085
MEDTRONIC SOFAMOR DANEK, INC.
EX0217085
In Commercial Distribution

  • 00643169981768 ()


  • Orthopaedic implant impactor, reusable
PLATE HOLDER EX0213120 CERVICAL
MEDTRONIC SOFAMOR DANEK, INC.
EX0213120
In Commercial Distribution

  • 00643169325968 ()


  • Surgical implant/trial-implant/sizer holder, reusable
EXTENDER EX0213039 SCREW 11CM - 4.75MAS
MEDTRONIC SOFAMOR DANEK, INC.
EX0213039
In Commercial Distribution

  • 00643169324145 ()


  • General internal orthopaedic fixation system implantation kit
EXTENDER EX0213037 SCREW 9CM - 4.75MAS
MEDTRONIC SOFAMOR DANEK, INC.
EX0213037
In Commercial Distribution

  • 00643169324121 ()


  • General internal orthopaedic fixation system implantation kit
EXTENDER EX0213035 SCREW 7CM - 4.75MAS
MEDTRONIC SOFAMOR DANEK, INC.
EX0213035
In Commercial Distribution

  • 00643169324107 ()


  • General internal orthopaedic fixation system implantation kit
RETRACTOR EX0213112 WIDE TIP
MEDTRONIC SOFAMOR DANEK, INC.
EX0213112
In Commercial Distribution

  • 00643169323254 ()


  • Surgical retractor/retraction system blade, reusable
DRILL BIT X0213054 14MM TRI FLAT
MEDTRONIC SOFAMOR DANEK, INC.
X0213054
In Commercial Distribution

  • 00643169323247 ()


  • Fluted surgical drill bit, reusable
DRILL BIT X0213057 17MM TRI FLAT
MEDTRONIC SOFAMOR DANEK, INC.
X0213057
In Commercial Distribution

  • 00643169323230 ()


  • Fluted surgical drill bit, reusable
DRILL BIT X0213056 16MM TRI FLAT
MEDTRONIC SOFAMOR DANEK, INC.
X0213056
In Commercial Distribution

  • 00643169323223 ()


  • Fluted surgical drill bit, reusable
DRILL BIT X0213055 15MM TRI FLAT
MEDTRONIC SOFAMOR DANEK, INC.
X0213055
In Commercial Distribution

  • 00643169323216 ()


  • Fluted surgical drill bit, reusable
RING CURETTE X0812028 8MM RIGHT HANDED
MEDTRONIC SOFAMOR DANEK, INC.
X0812028
In Commercial Distribution

  • 00643169322967 ()


  • Bone curette, reusable
TAP EX0113116 3.0 SMALL DIAMETER TIP
MEDTRONIC SOFAMOR DANEK, INC.
EX0113116
In Commercial Distribution

  • 00643169322325 ()


  • Bone tap, reusable
MEDIUM X0113201 ROTATE CUTTER
MEDTRONIC SOFAMOR DANEK, INC.
X0113201
Not in Commercial Distribution

  • 00643169322271 ()


  • Orthopaedic knife
TAMP EX0213177 BONE GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0213177
In Commercial Distribution

  • 00643169322257 ()


  • Surgical tamp, reusable
RASP EX0113127 CONVEX
MEDTRONIC SOFAMOR DANEK, INC.
EX0113127
In Commercial Distribution

  • 00643169322189 ()


  • Bone file/rasp, manual, reusable
SET SCREW EX0213010 RETAINING DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
EX0213010
In Commercial Distribution

  • 00643169322134 ()


  • Orthopaedic implant driver
DISTRACTOR EX1112065 4.75 TLIF
MEDTRONIC SOFAMOR DANEK, INC.
EX1112065
In Commercial Distribution

  • 00643169320345 ()


  • Orthopaedic surgical distractor, internal
5.5 STRAIGHT EX0213028 IMPLANT HOLDER
MEDTRONIC SOFAMOR DANEK, INC.
EX0213028
In Commercial Distribution

  • 00643169319622 ()


  • Surgical implant/trial-implant/sizer holder, reusable
DILATOR EX1112024 CORE
MEDTRONIC SOFAMOR DANEK, INC.
EX1112024
In Commercial Distribution

  • 00643169318854 ()


  • Laparoscopic access cannula dilator
TRIAL X1012446 6DEG 27MM x 10MM
MEDTRONIC SOFAMOR DANEK, INC.
X1012446
In Commercial Distribution

  • 00643169316720 ()

  • Angle: 6.0 degree
  • Length: 27.0 Millimeter
  • Height: 10.0 Millimeter


  • Metallic spinal interbody fusion cage
TRIAL X1012445 6DEG 22MM x 17MM
MEDTRONIC SOFAMOR DANEK, INC.
X1012445
Not in Commercial Distribution

  • 00643169316713 ()

  • Height: 17.0 Millimeter
  • Angle: 6.0 degree
  • Length: 22.0 Millimeter


  • Metallic spinal interbody fusion cage
TRIAL X1012444 6DEG 22MM x 16MM
MEDTRONIC SOFAMOR DANEK, INC.
X1012444
Not in Commercial Distribution

  • 00643169316706 ()

  • Length: 22.0 Millimeter
  • Height: 16.0 Millimeter
  • Angle: 6.0 degree


  • Metallic spinal interbody fusion cage
TRIAL X1012442 6DEG 22MM x 14MM
MEDTRONIC SOFAMOR DANEK, INC.
X1012442
Not in Commercial Distribution

  • 00643169316683 ()

  • Angle: 6.0 degree
  • Height: 14.0 Millimeter
  • Length: 22.0 Millimeter


  • Metallic spinal interbody fusion cage
TRIAL X1012440 6DEG 22MM x 12MM
MEDTRONIC SOFAMOR DANEK, INC.
X1012440
Not in Commercial Distribution

  • 00643169316669 ()

  • Angle: 6.0 degree
  • Height: 12.0 Millimeter
  • Length: 22.0 Millimeter


  • Metallic spinal interbody fusion cage
TRIAL X1012438 6DEG 22MM x 10MM
MEDTRONIC SOFAMOR DANEK, INC.
X1012438
Not in Commercial Distribution

  • 00643169316645 ()

  • Length: 22.0 Millimeter
  • Height: 10.0 Millimeter
  • Angle: 6.0 degree


  • Metallic spinal interbody fusion cage
TRIAL X1012436 0DEG 32MM x 16MM
MEDTRONIC SOFAMOR DANEK, INC.
X1012436
Not in Commercial Distribution

  • 00643169316621 ()

  • Height: 16.0 Millimeter
  • Length: 32.0 Millimeter
  • Angle: 0.0 degree


  • Metallic spinal interbody fusion cage
TRIAL X1012435 0DEG 32MM x 15MM
MEDTRONIC SOFAMOR DANEK, INC.
X1012435
Not in Commercial Distribution

  • 00643169316614 ()

  • Height: 15.0 Millimeter
  • Angle: 0.0 degree
  • Length: 32.0 Millimeter


  • Metallic spinal interbody fusion cage
TRIAL X1012433 0DEG 32MM x 13MM
MEDTRONIC SOFAMOR DANEK, INC.
X1012433
Not in Commercial Distribution

  • 00643169316591 ()

  • Length: 32.0 Millimeter
  • Angle: 0.0 degree
  • Height: 13.0 Millimeter


  • Metallic spinal interbody fusion cage
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