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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BLADE X07318138 CURVED FOURTH 130MM
MEDTRONIC SOFAMOR DANEK, INC.
X07318138
In Commercial Distribution

  • 00763000986124 ()


  • Surgical retractor/retraction system blade, reusable
BLADE X07318118 CURVED FOURTH 110MM
MEDTRONIC SOFAMOR DANEK, INC.
X07318118
In Commercial Distribution

  • 00763000986117 ()


  • Surgical retractor/retraction system blade, reusable
BLADE X07318197 STRAIGHT FOURTH 190MM
MEDTRONIC SOFAMOR DANEK, INC.
X07318197
In Commercial Distribution

  • 00763000986094 ()


  • Surgical retractor/retraction system blade, reusable
BLADE X07318137 STRAIGHT FOURTH 130MM
MEDTRONIC SOFAMOR DANEK, INC.
X07318137
In Commercial Distribution

  • 00763000986063 ()


  • Surgical retractor/retraction system blade, reusable
MOUSTACHE X07318009
MEDTRONIC SOFAMOR DANEK, INC.
X07318009
In Commercial Distribution

  • 00763000986032 ()


  • Surgical retraction system, reusable
RETRACTOR X07318003 HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X07318003
In Commercial Distribution

  • 00763000986018 ()


  • Hand-held surgical retractor, reusable
SCREWDRIVER X5598039 MDLX FINAL SET
MEDTRONIC SOFAMOR DANEK, INC.
X5598039
In Commercial Distribution

  • 00763000985592 ()


  • Surgical screwdriver, reusable
CLAMP X07318000 TABLE
MEDTRONIC SOFAMOR DANEK, INC.
X07318000
In Commercial Distribution

  • 00763000984793 ()


  • Medical table clamp
DISTRACTOR X0924032 32MM ALIF
MEDTRONIC SOFAMOR DANEK, INC.
X0924032
In Commercial Distribution

  • 00763000982430 ()


  • Orthopaedic surgical distractor, internal
DRILL X0624004 TCS ANGLED FIXED 2.5MM
MEDTRONIC SOFAMOR DANEK, INC.
X0624004
In Commercial Distribution

  • 00763000972073 ()


  • Fluted surgical drill bit, reusable
CANNULA X1119023 REUSABLE
MEDTRONIC SOFAMOR DANEK, INC.
X1119023
In Commercial Distribution

  • 00763000388942 ()


  • Bone access cannula
STYLET X1119022 REUSABLE TROCAR
MEDTRONIC SOFAMOR DANEK, INC.
X1119022
In Commercial Distribution

  • 00763000388935 ()


  • Bone access cannula
STYLET X1119021 REUSABLE BEVELED
MEDTRONIC SOFAMOR DANEK, INC.
X1119021
In Commercial Distribution

  • 00763000388928 ()


  • Bone access cannula
11mm Double Sided Rasp
MEDTRONIC SOFAMOR DANEK, INC.
EX0420050
In Commercial Distribution

  • 00763000388911 ()


  • Bone file/rasp, manual, reusable
STATION EX0420049 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0420049
In Commercial Distribution

  • 00763000387068 ()


  • Bone graft packing block
TAB BREAKER EX1019003 5.5/6 RMAS BI-DRTN
MEDTRONIC SOFAMOR DANEK, INC.
EX1019003
In Commercial Distribution

  • 00763000386634 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SCREWDRIVER X0320008 5.5 MAS W/OUT T-BAR
MEDTRONIC SOFAMOR DANEK, INC.
X0320008
In Commercial Distribution

  • 00763000386573 ()


  • Surgical screwdriver, reusable
REMOVER X1219005 CL INSERTER SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
X1219005
In Commercial Distribution

  • 00763000383312 ()


  • Orthopaedic implantation hammering attachment
HANDLE EX0320004 BALL
MEDTRONIC SOFAMOR DANEK, INC.
EX0320004
In Commercial Distribution

  • 00763000380809 ()


  • Surgical instrument handle, non-torque-limiting
RONGEUR X1119018 CURVED
MEDTRONIC SOFAMOR DANEK, INC.
X1119018
In Commercial Distribution

  • 00763000378844 ()


  • Orthopaedic joint/limb rongeur
COBB X1119017 CURVED 18MM WIDE
MEDTRONIC SOFAMOR DANEK, INC.
X1119017
In Commercial Distribution

  • 00763000378837 ()


  • Bone lever/elevator, reusable
COBB X1119016 CURVED 10MM WIDE
MEDTRONIC SOFAMOR DANEK, INC.
X1119016
In Commercial Distribution

  • 00763000378820 ()


  • Bone lever/elevator, reusable
TRIAL X1119014 CURVED H12XW22-12DEG
MEDTRONIC SOFAMOR DANEK, INC.
X1119014
In Commercial Distribution

  • 00763000378813 ()


  • Surgical implant template, reusable
TRIAL X1119013 CURVED H10XW22-12DEG
MEDTRONIC SOFAMOR DANEK, INC.
X1119013
In Commercial Distribution

  • 00763000378806 ()


  • Surgical implant template, reusable
TRIAL X1119011 CURVED H12XW18-6DEG
MEDTRONIC SOFAMOR DANEK, INC.
X1119011
In Commercial Distribution

  • 00763000378790 ()


  • Surgical implant template, reusable
TRIAL X1119010 CURVED H10XW18-6DEG
MEDTRONIC SOFAMOR DANEK, INC.
X1119010
In Commercial Distribution

  • 00763000378783 ()


  • Surgical implant template, reusable
TRIAL X1119009 CURVED H8XW18-6DEG
MEDTRONIC SOFAMOR DANEK, INC.
X1119009
In Commercial Distribution

  • 00763000378776 ()


  • Surgical implant template, reusable
GUIDE EX0220056 INTRADISCAL DRILL 9MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0220056
In Commercial Distribution

  • 00763000378325 ()


  • Surgical drill guide, reusable
GUIDE EX0220055 INTRADISCAL DRILL 8MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0220055
In Commercial Distribution

  • 00763000378318 ()


  • Surgical drill guide, reusable
DISTRACTOR X0919015 TLIF
MEDTRONIC SOFAMOR DANEK, INC.
X0919015
In Commercial Distribution

  • 00763000377670 ()


  • Orthopaedic surgical distractor, internal
SCREWDRIVER EX0220063 TORQUE LIMITING
MEDTRONIC SOFAMOR DANEK, INC.
EX0220063
In Commercial Distribution

  • 00763000374303 ()


  • Surgical screwdriver, reusable
COUNTER TORQUE EX0220062 ROD PUSHER
MEDTRONIC SOFAMOR DANEK, INC.
EX0220062
In Commercial Distribution

  • 00763000374297 ()


  • Orthopaedic counter-torque/rod-pushing instrument
COUNTER TORQUE EX0220061
MEDTRONIC SOFAMOR DANEK, INC.
EX0220061
In Commercial Distribution

  • 00763000374280 ()


  • Orthopaedic counter-torque/rod-pushing instrument
REDUCER X1119025 4.75
MEDTRONIC SOFAMOR DANEK, INC.
X1119025
In Commercial Distribution

  • 00763000371968 ()


  • Orthopaedic rod reducer
EXTENDER X1119024 CLOSED W/ D-LOCK 4.75
MEDTRONIC SOFAMOR DANEK, INC.
X1119024
In Commercial Distribution

  • 00763000371951 ()


  • Orthopaedic rod reducer
DISTRACTOR EX0220021 5MM TL 21MM WD WEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0220021
In Commercial Distribution

  • 00763000369828 ()


  • Orthopaedic surgical distractor, internal
TAP EX1119038 4 X 13MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1119038
In Commercial Distribution

  • 00763000369712 ()


  • Bone tap, reusable
SCREWDRIVER EX1119036 2.5 HEX
MEDTRONIC SOFAMOR DANEK, INC.
EX1119036
In Commercial Distribution

  • 00763000369699 ()


  • Surgical screwdriver, reusable
BENDING IRON EX0220029 TIGHT LEFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0220029
In Commercial Distribution

  • 00763000369460 ()


  • Manual orthopaedic bender, reusable
DILATOR X1119008 OL 20.8MM W/ LT OUT CH
MEDTRONIC SOFAMOR DANEK, INC.
X1119008
In Commercial Distribution

  • 00763000365240 ()


  • Laparoscopic access cannula dilator
DISTRACTOR X0619030 4.5X12MM SLF TPG SCW
MEDTRONIC SOFAMOR DANEK, INC.
X0619030
In Commercial Distribution

  • 00763000365165 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR X0619029 4.5X10MM SLF TPG SCW
MEDTRONIC SOFAMOR DANEK, INC.
X0619029
In Commercial Distribution

  • 00763000365158 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR X0120003 PLATE FLAT
MEDTRONIC SOFAMOR DANEK, INC.
X0120003
In Commercial Distribution

  • 00763000365134 ()


  • Orthopaedic surgical distractor, internal
LOCKER EX0220005 MAS
MEDTRONIC SOFAMOR DANEK, INC.
EX0220005
In Commercial Distribution

  • 00763000361211 ()


  • Orthopaedic fixation implant alignment tool
BLADE EX0120033 OLIF ROUND CEPHALAD 15CM
MEDTRONIC SOFAMOR DANEK, INC.
EX0120033
In Commercial Distribution

  • 00763000359713 ()


  • Surgical retractor/retraction system blade, reusable
BLADE EX0120031 OLIF ROUND CAUDAD 15CM
MEDTRONIC SOFAMOR DANEK, INC.
EX0120031
In Commercial Distribution

  • 00763000359690 ()


  • Surgical retractor/retraction system blade, reusable
BLADE EX0120030 OLIF ROUND CAUDAD 11CM
MEDTRONIC SOFAMOR DANEK, INC.
EX0120030
In Commercial Distribution

  • 00763000359683 ()


  • Surgical retractor/retraction system blade, reusable
REDUCER EX0120025 SEQUENTIAL WITH HEX
MEDTRONIC SOFAMOR DANEK, INC.
EX0120025
In Commercial Distribution

  • 00763000359430 ()


  • Orthopaedic rod reducer
FUNNEL EX1119006 BONE
MEDTRONIC SOFAMOR DANEK, INC.
EX1119006
In Commercial Distribution

  • 00763000356743 ()


  • Bone graft funnel
DRIVER X0117005 SET SCREW RETAINING 4.75
MEDTRONIC SOFAMOR DANEK, INC.
X0117005
In Commercial Distribution

  • 00763000356736 ()


  • Surgical screwdriver, reusable
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