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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INNER TRAY 9115897 CYLN ENDO GEN INSTR
MEDTRONIC SOFAMOR DANEK, INC.
9115897
In Commercial Distribution

  • 00721902163425 ()


  • Instrument tray, reusable
LIBERTY CLSD DRVR W/QCK CONN
MEDTRONIC SOFAMOR DANEK, INC.
X812-910
In Commercial Distribution

  • 00721902067655 ()


  • Orthopaedic implant driver
BONE X0201001 SMALL FOOT TAMP
MEDTRONIC SOFAMOR DANEK, INC.
X0201001
In Commercial Distribution

  • 00721902065606 ()


  • Surgical tamp, reusable
GAUGE X0101004 DEPTH TRIMLINE
MEDTRONIC SOFAMOR DANEK, INC.
X0101004
In Commercial Distribution

  • 00721902065590 ()


  • Orthopaedic bone calliper
PROBE X0601003 CDH 4.5 STRAIGHT
MEDTRONIC SOFAMOR DANEK, INC.
X0601003
In Commercial Distribution

  • 00721902064708 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
EXTENDED 3/16 ROD HOLDER
MEDTRONIC SOFAMOR DANEK, INC.
X820-555
In Commercial Distribution

  • 00721902059599 ()


  • Surgical implant/trial-implant/sizer holder, reusable
EXTENDED ROD PUSHER
MEDTRONIC SOFAMOR DANEK, INC.
X836-021
In Commercial Distribution

  • 00721902059582 ()


  • Orthopaedic counter-torque/rod-pushing instrument
EXT M8 FIXED DRIVER W/MOD HEAD
MEDTRONIC SOFAMOR DANEK, INC.
X858-959
In Commercial Distribution

  • 00721902059575 ()


  • Orthopaedic implant driver
EXTENDED AWL
MEDTRONIC SOFAMOR DANEK, INC.
X8691000
In Commercial Distribution

  • 00721902059483 ()


  • Bone awl, reusable
M8 ALIGNMENT GUIDE
MEDTRONIC SOFAMOR DANEK, INC.
X0401004
In Commercial Distribution

  • 00721902046988 ()


  • General internal orthopaedic fixation system implantation kit
FLEXIBLE FEELER PROBE, 2.5MM
MEDTRONIC SOFAMOR DANEK, INC.
X0601001
In Commercial Distribution

  • 00721902044847 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
MODIFIED FLEX. ARM ASSEMBLY
MEDTRONIC SOFAMOR DANEK, INC.
X955-525
In Commercial Distribution

  • 00721902044830 ()


  • Orthopaedic fixation implant alignment tool
M8 FIXED SCREWDRIVER W/POST
MEDTRONIC SOFAMOR DANEK, INC.
X0501005
In Commercial Distribution

  • 00721902043758 ()


  • Orthopaedic implant driver
M8MAS DRIVER WITH DRAIN HOLES
MEDTRONIC SOFAMOR DANEK, INC.
X0501002
In Commercial Distribution

  • 00721902043741 ()


  • Orthopaedic implant driver
EASY CLEAN M8MAS DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X0501001
In Commercial Distribution

  • 00721902043734 ()


  • Orthopaedic implant driver
INSTR 8570525 LGACY XLINK BNDR 4.5 L4.5
MEDTRONIC SOFAMOR DANEK, INC.
8570525
In Commercial Distribution

  • 00721902100666 ()


  • Manual orthopaedic bender, reusable
CYLN ENDO 18MM BASE CASE
MEDTRONIC SOFAMOR DANEK, INC.
9112498
In Commercial Distribution

  • 00721902097164 ()


  • Instrument tray, reusable
CYLN ENDO 18MM INNER TRAY
MEDTRONIC SOFAMOR DANEK, INC.
9112497
In Commercial Distribution

  • 00721902097140 ()


  • Instrument tray, reusable
CYLN ENDO 16MM BASE CASE
MEDTRONIC SOFAMOR DANEK, INC.
9112398
In Commercial Distribution

  • 00721902097065 ()


  • Instrument tray, reusable
CYLN ENDO 16MM INNER TRAY
MEDTRONIC SOFAMOR DANEK, INC.
9112397
In Commercial Distribution

  • 00721902096952 ()


  • Instrument tray, reusable
GUIDE 9110480 TREPHINE TPRD 18MM
MEDTRONIC SOFAMOR DANEK, INC.
9110480
In Commercial Distribution

  • 00721902096396 ()


  • General internal orthopaedic fixation system implantation kit
ADJUSTER 9110476 IMPLANT TPRD 18MM
MEDTRONIC SOFAMOR DANEK, INC.
9110476
In Commercial Distribution

  • 00721902096389 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
ADAPTER 9110470 SIZING TPRD 18MM
MEDTRONIC SOFAMOR DANEK, INC.
9110470
In Commercial Distribution

  • 00721902096372 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
HOLDER 9110462 IMPLANT TPRD 18/26MM
MEDTRONIC SOFAMOR DANEK, INC.
9110462
In Commercial Distribution

  • 00721902096358 ()


  • Surgical implant/trial-implant/sizer holder, reusable
REAMER 9110450 ADJ 18MM TPRD
MEDTRONIC SOFAMOR DANEK, INC.
9110450
In Commercial Distribution

  • 00721902096310 ()


  • Orthopaedic broach
SLEEVE 9110409 SWITCHING 18MM TPRD
MEDTRONIC SOFAMOR DANEK, INC.
9110409
In Commercial Distribution

  • 00721902096297 ()


  • Orthopaedic implantation sleeve, reusable
TPRD LAP 18MM INSTR INNER TRAY
MEDTRONIC SOFAMOR DANEK, INC.
9110497
In Commercial Distribution

  • 00721902096273 ()


  • Instrument tray, reusable
ADJUSTER 9110376 IMPLANT TPRD 16MM
MEDTRONIC SOFAMOR DANEK, INC.
9110376
In Commercial Distribution

  • 00721902096211 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
ADAPTER 9110375 SIZING TPRD 16MM
MEDTRONIC SOFAMOR DANEK, INC.
9110375
In Commercial Distribution

  • 00721902096204 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
HOLDER 9110368 IMPLANT TRPD 16/26MM
MEDTRONIC SOFAMOR DANEK, INC.
9110368
In Commercial Distribution

  • 00721902096198 ()


  • Surgical implant/trial-implant/sizer holder, reusable
HOLDER 9110366 IMPLANT TPRD 16/20MM
MEDTRONIC SOFAMOR DANEK, INC.
9110366
In Commercial Distribution

  • 00721902096174 ()


  • Surgical implant/trial-implant/sizer holder, reusable
DRIVER 9110365 IMPLANT TPRD SLV 16MM
MEDTRONIC SOFAMOR DANEK, INC.
9110365
In Commercial Distribution

  • 00721902096167 ()


  • Orthopaedic implantation sleeve, reusable
REAMER 9110352 ADJ TPRD 16MM
MEDTRONIC SOFAMOR DANEK, INC.
9110352
In Commercial Distribution

  • 00721902096150 ()


  • Orthopaedic broach
TPRD LAP 16MM INSTR BASE CASE
MEDTRONIC SOFAMOR DANEK, INC.
9110398
In Commercial Distribution

  • 00721902096129 ()


  • Instrument tray, reusable
GUIDE 9110280 TREPHINE TPRD 14MM
MEDTRONIC SOFAMOR DANEK, INC.
9110280
In Commercial Distribution

  • 00721902096075 ()


  • General internal orthopaedic fixation system implantation kit
ADJUSTER 9110276 IMPLANT TPRD 14MM
MEDTRONIC SOFAMOR DANEK, INC.
9110276
In Commercial Distribution

  • 00721902096068 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
ADAPTER 9110270 SIZING 14MM TPRD
MEDTRONIC SOFAMOR DANEK, INC.
9110270
In Commercial Distribution

  • 00721902096051 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
HOLDER 9110262 IMPLANT TPRD 14/23MM
MEDTRONIC SOFAMOR DANEK, INC.
9110262
In Commercial Distribution

  • 00721902096044 ()


  • Surgical implant/trial-implant/sizer holder, reusable
HOLDER 9110261 IMPLANT TPRD 14/20MM
MEDTRONIC SOFAMOR DANEK, INC.
9110261
In Commercial Distribution

  • 00721902096037 ()


  • Surgical implant/trial-implant/sizer holder, reusable
DRIVER 9110260 IMPLANT TPRD 14MM
MEDTRONIC SOFAMOR DANEK, INC.
9110260
In Commercial Distribution

  • 00721902096020 ()


  • Orthopaedic implantation sleeve, reusable
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