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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16X75MM MULTI TOOTH DIS BLADE
MEDTRONIC SOFAMOR DANEK, INC.
X0101675
In Commercial Distribution

  • 00681490917070 ()


  • Orthopaedic knife
BLADE X0101670 MULTI TOOTH DIS 16X70MM
MEDTRONIC SOFAMOR DANEK, INC.
X0101670
In Commercial Distribution

  • 00681490917063 ()


  • Orthopaedic knife
16X65MM MULTI TOOTH DIS BLADE
MEDTRONIC SOFAMOR DANEK, INC.
X0101665
In Commercial Distribution

  • 00681490917018 ()


  • Orthopaedic knife
BLADE X0101660 MULTI TOOTH DIS 16X60MM
MEDTRONIC SOFAMOR DANEK, INC.
X0101660
In Commercial Distribution

  • 00681490916981 ()


  • Orthopaedic knife
16X55MM MULTI TOOTH DIS BLADE
MEDTRONIC SOFAMOR DANEK, INC.
X0101655
In Commercial Distribution

  • 00681490916974 ()


  • Orthopaedic knife
INSTRUMENT 80615528 Q C COUNTER TORQUE
MEDTRONIC SOFAMOR DANEK, INC.
80615528
In Commercial Distribution

  • 00681490912402 ()


  • Orthopaedic counter-torque/rod-pushing instrument
INSTRUMENT 922505S SPERICAL LOCATING PIN
MEDTRONIC SOFAMOR DANEK, INC.
922505S
In Commercial Distribution

  • 00681490912259 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
INSTRUMENT 922502S Q C STRT PED SPATULA
MEDTRONIC SOFAMOR DANEK, INC.
922502S
In Commercial Distribution

  • 00681490912235 ()


  • General-purpose surgical spatula
INSTRUMENT 922501L Q C LONG SQUARE AWL
MEDTRONIC SOFAMOR DANEK, INC.
922501L
In Commercial Distribution

  • 00681490912211 ()


  • Bone awl, reusable
T-MESH THREADED INSERTOR
MEDTRONIC SOFAMOR DANEK, INC.
YIB0301-001
In Commercial Distribution

  • 00681490909471 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
P-MESH THREADED INSERTOR
MEDTRONIC SOFAMOR DANEK, INC.
YIB0101-001
Not in Commercial Distribution

  • 00681490909464 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
T-HANDLE W/ MINI HUDSON QC
MEDTRONIC SOFAMOR DANEK, INC.
X0101012
In Commercial Distribution

  • 00681490906753 ()


  • Orthopaedic implant driver
EGG HANDLE PEDICLE AWL
MEDTRONIC SOFAMOR DANEK, INC.
X0301004
In Commercial Distribution

  • 00681490906722 ()


  • Bone awl, reusable
CASE 8959182 18MM INSTRUMENT INNER TRAY
MEDTRONIC SOFAMOR DANEK, INC.
8959182
In Commercial Distribution

  • 00681490906333 ()


  • Instrument tray, reusable
INSTRUMENT 8950003 TAPRD IMP DRVR WRENCH
MEDTRONIC SOFAMOR DANEK, INC.
8950003
In Commercial Distribution

  • 00681490904810 ()


  • Orthopaedic implant driver
INSTRUMENT 8691005 STAPLE IMPACTOR
MEDTRONIC SOFAMOR DANEK, INC.
8691005
In Commercial Distribution

  • 00681490902816 ()


  • Orthopaedic implant impactor, reusable
M8 MAS DRIVER W/ BALL DETENT
MEDTRONIC SOFAMOR DANEK, INC.
X1000007
In Commercial Distribution

  • 00681490902250 ()


  • Orthopaedic implant driver
5MM X 10MM RONGUER
MEDTRONIC SOFAMOR DANEK, INC.
X1000005
In Commercial Distribution

  • 00681490902236 ()


  • Orthopaedic joint/limb rongeur
4MM RING CURETTE
MEDTRONIC SOFAMOR DANEK, INC.
X1000004
In Commercial Distribution

  • 00681490902229 ()


  • Bone curette, reusable
REVERSE COMPRESSOR
MEDTRONIC SOFAMOR DANEK, INC.
X1000003
In Commercial Distribution

  • 00681490902205 ()


  • Orthopaedic surgical distractor, internal
INSTRUMENT 6905774 ROD HOLDER
MEDTRONIC SOFAMOR DANEK, INC.
6905774
In Commercial Distribution

  • 00681490886406 ()


  • Manual orthopaedic bender, reusable
INSTR 8616035 DISMANTLING SOCKET PRAXIS
MEDTRONIC SOFAMOR DANEK, INC.
8616035
In Commercial Distribution

  • 00673978951744 ()


  • Surgical screwdriver, reusable
INSTRUMENT 8081533 TSRH DUAL SCRDR SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
8081533
In Commercial Distribution

  • 00673978947884 ()


  • Surgical drill guide, reusable
INSTRUMENT 907-606 GRAFT IMPACTOR
MEDTRONIC SOFAMOR DANEK, INC.
907-606
In Commercial Distribution

  • 00673978929361 ()


  • General internal orthopaedic fixation system implantation kit
INSTRUMENT 907-409 DISC RONGEUR
MEDTRONIC SOFAMOR DANEK, INC.
907-409
In Commercial Distribution

  • 00673978929149 ()


  • Orthopaedic joint/limb rongeur
INSTRUMENT 822-365 ATL STRAIGHT AWL
MEDTRONIC SOFAMOR DANEK, INC.
822-365
In Commercial Distribution

  • 00673978928630 ()


  • Bone awl, reusable
SPEC 18MM/12MM WORKING CHANNEL
MEDTRONIC SOFAMOR DANEK, INC.
Y900-831-B
Not in Commercial Distribution

  • 00673978816982 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SPEC 18MM/10MM WORKING CHANNEL
MEDTRONIC SOFAMOR DANEK, INC.
Y900-830-A
Not in Commercial Distribution

  • 00673978816975 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SPEC 16MM/10MM WORKING CHANNEL
MEDTRONIC SOFAMOR DANEK, INC.
Y900-631-C
Not in Commercial Distribution

  • 00673978816968 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SPECL 16MM/8MM WORKING CHANNEL
MEDTRONIC SOFAMOR DANEK, INC.
Y900-630-A
Not in Commercial Distribution

  • 00673978816951 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SPECL 14MM/8MM WORKING CHANNEL
MEDTRONIC SOFAMOR DANEK, INC.
Y900-431-A
Not in Commercial Distribution

  • 00673978816944 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SPECL 14MM/6MM WORKING CHANNEL
MEDTRONIC SOFAMOR DANEK, INC.
Y900-430-A
Not in Commercial Distribution

  • 00673978816937 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SPECL 12MM/8MM WORKING CHANNEL
MEDTRONIC SOFAMOR DANEK, INC.
Y900-231-A
Not in Commercial Distribution

  • 00673978816920 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SPECL 12MM/6MM WORKING CHANNEL
MEDTRONIC SOFAMOR DANEK, INC.
Y900-230-A
Not in Commercial Distribution

  • 00673978816913 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
GUIDE X0699040 GRADUATED WIRE LEN 9 INCH
MEDTRONIC SOFAMOR DANEK, INC.
X0699040
In Commercial Distribution

  • 00673978816241 ()


  • General internal orthopaedic fixation system implantation kit
ATLANTIS 3.0 X 15MM TAP
MEDTRONIC SOFAMOR DANEK, INC.
X0699033
In Commercial Distribution

  • 00673978816234 ()


  • Bone tap, reusable
ATLANTIS 3.0 X 14MM TAP
MEDTRONIC SOFAMOR DANEK, INC.
X0699032
In Commercial Distribution

  • 00673978816227 ()


  • Bone tap, reusable
3D SCREWDRIVER FOR RAT HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X0699021
In Commercial Distribution

  • 00673978816111 ()


  • Surgical instrument handle, non-torque-limiting
3D SOCKET SHAFT FOR RAT HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X0699020
In Commercial Distribution

  • 00673978816104 ()


  • Surgical instrument handle, non-torque-limiting
3D 7.5 TAP FOR RATCHET HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X0699019
In Commercial Distribution

  • 00673978816098 ()


  • Bone tap, reusable
3D 6.5 TAP FOR RATCHET HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X0699018
In Commercial Distribution

  • 00673978816081 ()


  • Bone tap, reusable
3D 5.5 TAP FOR RATCHET HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X0699017
In Commercial Distribution

  • 00673978816074 ()


  • Bone tap, reusable
FLEX FEELER PROBE, 2MM
MEDTRONIC SOFAMOR DANEK, INC.
X0699011
In Commercial Distribution

  • 00673978816012 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
CORNERSTONE TRIAL CAP
MEDTRONIC SOFAMOR DANEK, INC.
X0699005
In Commercial Distribution

  • 00673978815961 ()


  • Surgical implant template, reusable
4.5 TAP
MEDTRONIC SOFAMOR DANEK, INC.
X0699003
In Commercial Distribution

  • 00673978815947 ()


  • Bone tap, reusable
M8 DUAL PURPOSE IMPLANT HOLDER
MEDTRONIC SOFAMOR DANEK, INC.
X0699001
In Commercial Distribution

  • 00673978815923 ()


  • Surgical implant/trial-implant/sizer holder, reusable
9CM-11CM DPTH X 10 DIA CUTTER
MEDTRONIC SOFAMOR DANEK, INC.
X0599110
In Commercial Distribution

  • 00673978815916 ()


  • Orthopaedic knife
9CM-11CM DPTH X 9 DIA CUTTER
MEDTRONIC SOFAMOR DANEK, INC.
X0599109
In Commercial Distribution

  • 00673978815909 ()


  • Orthopaedic knife
9CM-11CM DPTH X 8 DIA CUTTER
MEDTRONIC SOFAMOR DANEK, INC.
X0599108
In Commercial Distribution

  • 00673978815893 ()


  • Orthopaedic knife
CUTTER X0599107 9CM-11CM DPTH X 7 DIA
MEDTRONIC SOFAMOR DANEK, INC.
X0599107
In Commercial Distribution

  • 00673978815886 ()


  • Orthopaedic knife
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