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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SCREWDRIVER EX0212014 T25
MEDTRONIC SOFAMOR DANEK, INC.
EX0212014
In Commercial Distribution

  • 00643169156043 ()


  • Orthopaedic implant driver
DRIVER EX0212730 TAPERED SQUARE
MEDTRONIC SOFAMOR DANEK, INC.
EX0212730
In Commercial Distribution

  • 00643169149977 ()


  • Orthopaedic implant driver
Driver
K2M, INC.
801-90214
In Commercial Distribution

  • 10888857307193 ()
801-90214

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Single Tooth Movement Screw Driver
ORTHOSOURCE
2013
In Commercial Distribution

  • D91120130 ()


  • Orthodontic palate expander/teeth aligner, self-removable
Driver Size 10 Short
K2M, INC.
6401-90106
In Commercial Distribution

  • 10888857328297 ()
6401-90106

  • Surgical screwdriver, reusable
Expansion Driver
K2M, INC.
7012-90001
In Commercial Distribution

  • 10888857326873 ()
7012-90001

  • Orthopaedic prosthesis implantation positioning instrument, reusable
DRIVER X1212007 PEEK MAS LOCK SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
X1212007
In Commercial Distribution

  • 00643169309159 ()


  • Orthopaedic implant driver
DRIVER X1212005 5.5 MAS LOCK SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
X1212005
In Commercial Distribution

  • 00643169309135 ()


  • Orthopaedic implant driver
DRIVER EX1012404 PROVISIONAL
MEDTRONIC SOFAMOR DANEK, INC.
EX1012404
In Commercial Distribution

  • 00643169309111 ()


  • Orthopaedic implant driver
INST KIT 9735130 DRIVER SPINE CLAMP
MEDTRONIC NAVIGATION, INC.
9735130
In Commercial Distribution

  • 00643169308886 ()


  • Multi-purpose stereotactic surgery system
SETSCREW DRIVER EX1012313 U-JOINT
MEDTRONIC SOFAMOR DANEK, INC.
EX1012313
In Commercial Distribution

  • 00643169294646 ()


  • Orthopaedic implant driver
SCREW DRIVER EX1012312 T25 U-JOINT
MEDTRONIC SOFAMOR DANEK, INC.
EX1012312
In Commercial Distribution

  • 00643169294639 ()


  • Orthopaedic implant driver
Expansion Driver, Size Long
K2M, INC.
7012-90094
In Commercial Distribution

  • 10888857394025 ()
7012-90094

  • Orthopaedic prosthesis implantation positioning instrument, reusable
SLEEVE EX1012056 SCREW DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
EX1012056
In Commercial Distribution

  • 00643169279957 ()


  • Orthopaedic implant driver
Driver, Size 8
K2M, INC.
7012-90095
In Commercial Distribution

  • 10888857391697 ()
7012-90095

  • Orthopaedic prosthesis implantation positioning instrument, reusable
DRIVER 9010001262 TWIST
MEDTRONIC SOFAMOR DANEK, INC.
9010001262
In Commercial Distribution

  • 00643169275393 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER 9010001261 STRAIGHT
MEDTRONIC SOFAMOR DANEK, INC.
9010001261
In Commercial Distribution

  • 00643169275386 ()


  • Orthopaedic implant driver
DRIVER X1212006 6.35 MAS LOCK SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
X1212006
In Commercial Distribution

  • 00643169309142 ()


  • Orthopaedic implant driver
SLEEVE EX1112018 DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
EX1112018
In Commercial Distribution

  • 00643169293953 ()


  • Orthopaedic implant driver
SCREWDRIVER EX0812005 SLEEVED - 3.2MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0812005
In Commercial Distribution

  • 00643169289994 ()


  • Orthopaedic implant driver
Tapered Driver, Size Size 10
K2M, INC.
7501-90024
In Commercial Distribution

  • 10888857361928 ()
7501-90024

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Driver Height/Angle
K2M, INC.
7501-90025
In Commercial Distribution

  • 10888857361911 ()
7501-90025

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Non-Tapered Driver, Size Size 10
K2M, INC.
7501-90026
In Commercial Distribution

  • 10888857361904 ()
7501-90026

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Contraangle driver for Multiunit micro screw
ODONTIT S.A.
IN-THDC-UNI
In Commercial Distribution

  • D914INTHDCUNI0 ()
IN-THDC-UNI

  • Screw endosteal dental implant, two-piece
Internal hex SYSTEMS SGI SERIES DRIVER FOR RATCHET
ODONTIT S.A.
IHTL
In Commercial Distribution

  • D914IHTL0 ()
IHTL

  • Screw endosteal dental implant, two-piece
Internal hex driver short
ODONTIT S.A.
IHTC
In Commercial Distribution

  • D914IHTC0 ()
IHTC

  • Screw endosteal dental implant, two-piece
Internal hex SYSTEMS SGI SERIES DRIVER FOR CONTRAANGLE
ODONTIT S.A.
IHCL
In Commercial Distribution

  • D914IHCL0 ()
IHCL

  • Screw endosteal dental implant, two-piece
DRIVER X0512188 5.5 MAS T-25 OSTEOGRIP
MEDTRONIC SOFAMOR DANEK, INC.
X0512188
In Commercial Distribution

  • 00643169191440 ()


  • Orthopaedic implant driver
MIDLINE TEMPLATE X0512213 SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
X0512213
In Commercial Distribution

  • 00643169190153 ()


  • Surgical screwdriver, reusable
Angled Lateral Inserter Driver, Size Driver
K2M, INC.
3201-90288
In Commercial Distribution

  • 10888857059283 ()
3201-90288

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Slap Hammer
K2M, INC.
3201-90267
In Commercial Distribution

  • 10888857059221 ()
3201-90267

  • Surgical mallet
Non-Tapered Universal Driver Size 10
K2M, INC.
3608-90076
In Commercial Distribution

  • 10888857082977 ()
3608-90076

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Universal Tapered Driver Size 10
K2M, INC.
3608-90075
In Commercial Distribution

  • 10888857082960 ()
3608-90075

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Non-Tapered Driver Size 10
K2M, INC.
3608-90038
In Commercial Distribution

  • 10888857082625 ()
3608-90038

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tapered Driver Size 10
K2M, INC.
3608-90037
In Commercial Distribution

  • 10888857082618 ()
3608-90037

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Slap Hammer
K2M, INC.
3303-90052
In Commercial Distribution

  • 10888857075610 ()
3303-90052

  • Surgical mallet
Small Mallet
K2M, INC.
402-90048
In Commercial Distribution

  • 10888857088214 ()
402-90048

  • Surgical mallet
Tapered Driver, Hex Size 2.5
K2M, INC.
3901-90016
In Commercial Distribution

  • 10888857084599 ()
3901-90016

  • Orthopaedic implant driver
Large Mallet
K2M, INC.
702-90052
In Commercial Distribution

  • 10888857127142 ()
702-90052

  • Surgical mallet
DRIVER 5584334 FAS LOCK SLEEVE 5.5/6.0
MEDTRONIC SOFAMOR DANEK, INC.
5584334
In Commercial Distribution

  • 00643169016149 ()


  • Surgical screwdriver, reusable
DRIVER 5584280 FAS STANDARD 5.5/6.0
MEDTRONIC SOFAMOR DANEK, INC.
5584280
In Commercial Distribution

  • 00643169016132 ()


  • Surgical screwdriver, reusable
DRIVER EX0511176 RETAIN TWIST W/ HUDSON
MEDTRONIC SOFAMOR DANEK, INC.
EX0511176
In Commercial Distribution

  • 00643169014886 ()


  • Orthopaedic implant driver
SLEEVE X0511182 4.75 MAS
MEDTRONIC SOFAMOR DANEK, INC.
X0511182
In Commercial Distribution

  • 00643169013766 ()


  • Orthopaedic implant driver
Socket Driver
K2M, INC.
5401-90005
In Commercial Distribution

  • 10888857152939 ()
5401-90005

  • Orthopaedic prosthesis implantation positioning instrument, reusable
SLEEVE 2342402 LOCKING MPA SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
2342402
In Commercial Distribution

  • 00643169007604 ()


  • Surgical screwdriver, reusable
Cannulated Power Driver Attachment
K2M, INC.
5101-90023
In Commercial Distribution

  • 10888857104099 ()
5101-90023

  • Drilling power tool attachment, basic
Flex Shaft Tapered Driver Size 20
K2M, INC.
4508-90130
In Commercial Distribution

  • 10888857095809 ()
4508-90130

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Flex Shaft Non-tapered Driver Size 20
K2M, INC.
4508-90129
In Commercial Distribution

  • 10888857095793 ()
4508-90129

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tapered Driver Size 20
K2M, INC.
4508-90063
In Commercial Distribution

  • 10888857095441 ()
4508-90063

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Non-Tapered Driver Size 20
K2M, INC.
4508-90060
In Commercial Distribution

  • 10888857095410 ()
4508-90060

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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