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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CDH PLUG DRIVER-T25-U/V JOINT
MEDTRONIC SOFAMOR DANEK, INC.
X0403009
In Commercial Distribution

  • 00721902794148 ()


  • Orthopaedic implant driver
HEX DRIVER X1103002 WITH AO CHUCK 2.5MM
MEDTRONIC SOFAMOR DANEK, INC.
X1103002
In Commercial Distribution

  • 00721902999093 ()


  • Orthopaedic implant driver
SQUARE DRIVE SHAFT 2.5MM HEX
MEDTRONIC SOFAMOR DANEK, INC.
X1003022
In Commercial Distribution

  • 00721902999000 ()


  • Surgical screwdriver, reusable
INSTRUMENT 9790914 REVISION INSTRUMENT
MEDTRONIC SOFAMOR DANEK, INC.
9790914
In Commercial Distribution

  • 00721902989643 ()


  • Surgical screwdriver, reusable
INSTRUMENT 9790903 HOLDING PIN DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
9790903
In Commercial Distribution

  • 00721902989544 ()


  • Orthopaedic implant driver
INSTRUMENT 9790913 DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
9790913
In Commercial Distribution

  • 00721902989636 ()


  • Surgical screwdriver, reusable
LOCKSCREW DRIVER X0703484 1 INCH PHEN HN
MEDTRONIC SOFAMOR DANEK, INC.
X0703484
In Commercial Distribution

  • 00721902947704 ()


  • Surgical screwdriver, reusable
INSTRUMENT 7480147 DRV QUICK CONNECT T27
MEDTRONIC SOFAMOR DANEK, INC.
7480147
In Commercial Distribution

  • 00721902857089 ()


  • Surgical screwdriver, reusable
INSTRUMENT 7480144 DRV BREAK OFF 6.35 HX
MEDTRONIC SOFAMOR DANEK, INC.
7480144
In Commercial Distribution

  • 00721902853586 ()


  • Surgical screwdriver, reusable
INSTRUMENT 7480131 PROVISIONAL DRV SHORT
MEDTRONIC SOFAMOR DANEK, INC.
7480131
In Commercial Distribution

  • 00721902853579 ()


  • Surgical screwdriver, reusable
HANDPIECE 8004100 BATERY POWERD DRIVER
MEDTRONIC PS MEDICAL, INC.
8004100
In Commercial Distribution

  • 00721902805868 ()


  • Bone/joint surgical power tool motor, electric
TRAY 8004200 BATTERY POWERED DRIVER
MEDTRONIC PS MEDICAL, INC.
8004200
In Commercial Distribution

  • 00721902805509 ()


  • Instrument tray, reusable
INSTRUMENT 6276010 FORK HAMMER
MEDTRONIC SOFAMOR DANEK, INC.
6276010
In Commercial Distribution

  • 00721902766138 ()


  • Surgical mallet
INSTRUMENT 7480130 DRIVER PROVISIONAL
MEDTRONIC SOFAMOR DANEK, INC.
7480130
In Commercial Distribution

  • 00721902751745 ()


  • Surgical screwdriver, reusable
INSTRUMENT 7480205 DUAL PURPOSE SCRWDRVR
MEDTRONIC SOFAMOR DANEK, INC.
7480205
In Commercial Distribution

  • 00721902750908 ()


  • Surgical screwdriver, reusable
INSTRUMENT 7480117 MAS SCREWDRVR T BASIC
MEDTRONIC SOFAMOR DANEK, INC.
7480117
In Commercial Distribution

  • 00721902750885 ()


  • Surgical screwdriver, reusable
INSTRUMENT 7480116 MAS SCREWDRVR T BASIC
MEDTRONIC SOFAMOR DANEK, INC.
7480116
In Commercial Distribution

  • 00721902750878 ()


  • Surgical screwdriver, reusable
INSTRUMENT 7480280 FIXED SCREWDRIVER
MEDTRONIC SOFAMOR DANEK, INC.
7480280
In Commercial Distribution

  • 00721902746932 ()


  • Orthopaedic implant driver
INSTRUMENT 8110530 3.0MM HEX DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
8110530
In Commercial Distribution

  • 00721902744600 ()


  • Surgical screwdriver, reusable
INSTRUMENT 853-630 SCREWDRIVER
MEDTRONIC SOFAMOR DANEK, INC.
853-630
In Commercial Distribution

  • 00721902742019 ()


  • Surgical screwdriver, reusable
EXTENDED PROV. PLUG DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X84687E
Not in Commercial Distribution

  • 00721902170126 ()


  • Orthopaedic implant driver
INSTRUMENT 8682050 M8 REDUCTN MAS SCRWDR
MEDTRONIC SOFAMOR DANEK, INC.
8682050
In Commercial Distribution

  • 00721902167850 ()


  • Surgical screwdriver, reusable
CAP 9115877 DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
9115877
In Commercial Distribution

  • 00721902163692 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
DRIVER 9110260 IMPLANT TPRD 14MM
MEDTRONIC SOFAMOR DANEK, INC.
9110260
In Commercial Distribution

  • 00721902096020 ()


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

  • 00721902067655 ()


  • Orthopaedic implant driver
EXT M8 FIXED DRIVER W/MOD HEAD
MEDTRONIC SOFAMOR DANEK, INC.
X858-959
In Commercial Distribution

  • 00721902059575 ()


  • Orthopaedic implant driver
INSTRUMENT 8910640 SCREWDRIVER
MEDTRONIC SOFAMOR DANEK, INC.
8910640
In Commercial Distribution

  • 00721902053269 ()


  • Surgical screwdriver, reusable
DRIVER 9110365 IMPLANT TPRD SLV 16MM
MEDTRONIC SOFAMOR DANEK, INC.
9110365
In Commercial Distribution

  • 00721902096167 ()


  • Orthopaedic implantation sleeve, reusable
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
INSTRUMENT 858-959 IG M8 FIXED SCRWDRVER
MEDTRONIC SOFAMOR DANEK, INC.
858-959
In Commercial Distribution

  • 00721902038662 ()


  • Surgical screwdriver, reusable
ACCY KIT 355015 BURR HOLE
MEDTRONIC, INC.
355015
Not in Commercial Distribution

  • 00721902036378 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
INSTRUMENT 8361954 TSH 3D VB TH PST SCDR
MEDTRONIC SOFAMOR DANEK, INC.
8361954
In Commercial Distribution

  • 00721902034169 ()

  • 3.5mm


  • Orthopaedic implant driver
INSTRUMENT 8361953 TSRH 3D VBR THR NT DR
MEDTRONIC SOFAMOR DANEK, INC.
8361953
In Commercial Distribution

  • 00721902033551 ()

  • 7.5mm


  • Surgical screwdriver, reusable
Lumbar Interbody Fusion System (OLLIF) Mallet
ADVANCED RESEARCH MEDICAL LLC
01-11
In Commercial Distribution

  • 00850014575489 ()
01-11

  • Surgical mallet
T10 Torque Driver
SUBCHONDRAL SOLUTIONS, INC.
10-4010
In Commercial Distribution

  • 00850017962422 ()
10-4010

  • Orthopaedic bone screw, non-bioabsorbable, sterile
2.5mm Ball Driver
KICO KNEE INNOVATION COMPANY PTY LIMITED
11100
In Commercial Distribution

  • 00850012315124 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
3.5mm Hex Driver
KICO KNEE INNOVATION COMPANY PTY LIMITED
10800
In Commercial Distribution

  • 00850012315117 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Headless Compression System 2.0mm Hex Driver Shaft Cannulated
Osteocentric Technologies, Inc.
EX01-0033
In Commercial Distribution

  • 00850015496394 ()
EX01-0033

  • Surgical screwdriver, reusable
Headless Compression System 1.5mm Hex Driver Shaft Cannulated
Osteocentric Technologies, Inc.
EX01-0032
In Commercial Distribution

  • 00850015496387 ()
EX01-0032

  • Surgical screwdriver, reusable
Driver, K-Wire, 7.5mm, Catamaran
TENON MEDICAL, INC.
40396
In Commercial Distribution

  • 00850033676495 ()
40396

  • Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
K-Wire Driver, Catamaran
TENON MEDICAL, INC.
40370
In Commercial Distribution

  • 00850033676358 ()
40370

  • Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
Alert Display Driver (ADD) - Configuration 2 (curved)
AMPLION CLINICAL COMMUNICATIONS, INC.
D-ADD-X-2
Not in Commercial Distribution

  • 00850016398024 ()
D-ADD-X-2

  • Nurse call system
Alert Display Driver (ADD) - Configuration 1
AMPLION CLINICAL COMMUNICATIONS, INC.
D-ADD-X-1
Not in Commercial Distribution

  • 00850016398017 ()
D-ADD-X-1

  • Nurse call system
Midface Reconstruction kit
Materialise NV
SD980.032
In Commercial Distribution

  • 05420060380761 ()
SD980.032

  • Custom-made organ/bone anatomy model/surgical guide kit
Mandible Reconstruction kit
Materialise NV
SD980.031
In Commercial Distribution

  • 05420060380754 ()
SD980.031

  • Custom-made organ/bone anatomy model/surgical guide kit
Titanium 3D Printed Guide, Bone harvesting
Materialise NV
SD980.028
In Commercial Distribution

  • 05420060380747 ()
SD980.028

  • Custom-made orthopaedic/craniofacial surgical guide
DRIVER EX0616017 HEX RETAINING
MEDTRONIC SOFAMOR DANEK, INC.
EX0616017
In Commercial Distribution

  • 00643169834422 ()


  • Surgical screwdriver, reusable
DRIVER EX0616012 SHORTEN T8-T10
MEDTRONIC SOFAMOR DANEK, INC.
EX0616012
In Commercial Distribution

  • 00643169800106 ()


  • Surgical screwdriver, reusable
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