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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Universal screw driver, T20
UNITED ORTHOPEDIC CORP.
9208-1103
In Commercial Distribution

  • 04719872142591 ()
9208-1103

  • Surgical screwdriver, reusable
Screw driver, T20
UNITED ORTHOPEDIC CORP.
9208-1102
In Commercial Distribution

  • 04719872142584 ()
9208-1102

  • Surgical screwdriver, reusable
Driver handle, 3/8" SQ
UNITED ORTHOPEDIC CORP.
9415-1302
In Commercial Distribution

  • 04719872140177 ()


  • Surgical instrument handle, non-torque-limiting
USTAR II Stem trial driver
UNITED ORTHOPEDIC CORP.
9315-1102
In Commercial Distribution

  • 04719872140160 ()


  • Surgical instrument handle, non-torque-limiting
A mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral surgical intervention.
ENTER MEDICAL CORPORATION
PN-2002
In Commercial Distribution

  • 04719872108795 ()


  • Mouth gag, non-adjustable
Cup impactor driver
UNITED ORTHOPEDIC CORP.
9206-1118
In Commercial Distribution

  • 04719872141525 ()


  • Surgical screwdriver, reusable
DRIVER, SET SCREW
Pioneer Surgical Technology, Inc.
23-SETSCREWINS
Not in Commercial Distribution

  • 00846468027490 ()


  • General internal orthopaedic fixation system implantation kit
NUT DRIVER
Pioneer Surgical Technology, Inc.
23-NUTDRIVER
Not in Commercial Distribution

  • 00846468027391 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER, TORQUE LIMITING
Pioneer Surgical Technology, Inc.
21-TORQ-HANDLE
Not in Commercial Distribution

  • 00846468025960 ()


  • General internal orthopaedic fixation system implantation kit
CROSSLINK FINAL DRIVER
Xtant Medical Holdings, Inc.
02-XLNK-FLDRIVER
Not in Commercial Distribution

  • 00846468006372 ()
02-XLNK-FLDRIVER

  • General internal orthopaedic fixation system implantation kit
Final Driver, Extended
Pioneer Surgical Technology, Inc.
21-EXTDFINALDRV-TL
Not in Commercial Distribution

21-EXTDFINALDRV-TL

  • Orthopaedic inorganic implant inserter/extractor, reusable
SCREW DRIVER, BONE SCREW
Pioneer Surgical Technology, Inc.
21-DRIVER-TF
Not in Commercial Distribution

21-DRIVER-TF

  • Surgical screwdriver, reusable
SCREW DRIVER, BONE SCREW
Pioneer Surgical Technology, Inc.
21-DRIVER
Not in Commercial Distribution

21-DRIVER

  • Surgical screwdriver, reusable
Driver
Pioneer Surgical Technology, Inc.
83-DRIVER
Not in Commercial Distribution

83-DRIVER

  • Orthopaedic counter-torque/rod-pushing instrument
DRIVER, X-LINK
Pioneer Surgical Technology, Inc.
10-XLINKDRIVER
Not in Commercial Distribution

10-XLINKDRIVER

  • General internal orthopaedic fixation system implantation kit
Cup positioner, offset
UNITED ORTHOPEDIC CORP.
9207-1303
In Commercial Distribution

  • 04719872143246 ()
9207-1303

  • Orthopaedic inorganic implant inserter/extractor, reusable
Cup positioner, straight
UNITED ORTHOPEDIC CORP.
9207-1103
In Commercial Distribution

  • 04719872143239 ()
9207-1103

  • Orthopaedic inorganic implant inserter/extractor, reusable
Set screw driver adaptor, T8
UNITED ORTHOPEDIC CORP.
9315-5101-RC
In Commercial Distribution

  • 04719872143222 ()
9315-5101-RC

  • Orthopaedic implant-instrument extension adaptor, reusable
DRIVER, TORQUE LIMITING
Pioneer Surgical Technology, Inc.
21-TORQ-HANDLE
Not in Commercial Distribution

21-TORQ-HANDLE

  • General internal orthopaedic fixation system implantation kit
SCREW DRIVER, INTERNAL SET SCREW
Pioneer Surgical Technology, Inc.
21-FINALDRIV-TL
Not in Commercial Distribution

21-FINALDRIV-TL

  • Surgical screwdriver, reusable
SCREW DRIVER, INTERNAL SET SCREW
Pioneer Surgical Technology, Inc.
21-FINALDRIVER
Not in Commercial Distribution

21-FINALDRIVER

  • Surgical screwdriver, reusable
CERVICAL DRIVER, MODULAR
Pioneer Surgical Technology, Inc.
20-DRIVER-CL
Not in Commercial Distribution

20-DRIVER-CL

  • Orthopaedic inorganic implant inserter/extractor, reusable
CERVICAL DRIVER
Pioneer Surgical Technology, Inc.
20-DRIVER
Not in Commercial Distribution

20-DRIVER

  • Orthopaedic inorganic implant inserter/extractor, reusable
FINAL DRIVER
Pioneer Surgical Technology, Inc.
10-FINALDRIVER
Not in Commercial Distribution

10-FINALDRIVER

  • General internal orthopaedic fixation system implantation kit
Comet Lumbar Implant Driver
BAUI BIOTECH CO. LTD.
420-1724
In Commercial Distribution

  • 04718005159871 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
3mm Hex Screw Driver
BAUI BIOTECH CO. LTD.
406-0830A
In Commercial Distribution

  • 04718005155231 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
DRIVER, X-LINK®
Pioneer Surgical Technology, Inc.
10-XLINKDRIVER
Not in Commercial Distribution

  • 00846468022297 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER, TORQUE LIMITING
Pioneer Surgical Technology, Inc.
10-TLHANDLE
Not in Commercial Distribution

  • 00846468022181 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER, ROD TO ROD
Pioneer Surgical Technology, Inc.
10-RDDRIVER
Not in Commercial Distribution

  • 00846468021610 ()


  • General internal orthopaedic fixation system implantation kit
FINAL DRIVER
Pioneer Surgical Technology, Inc.
10-FINALDRIVER
Not in Commercial Distribution

  • 00846468020637 ()


  • General internal orthopaedic fixation system implantation kit
FINAL DRIVER
Pioneer Surgical Technology, Inc.
05-FINALDRIVER
Not in Commercial Distribution

  • 00846468050658 ()
05-FINALDRIVER

  • General internal orthopaedic fixation system implantation kit
Disposable Torque-Limiting Final Driver
Pioneer Surgical Technology, Inc.
21-SU-TLFNLDRV-S
Not in Commercial Distribution

  • 00846468050580 ()


  • Orthopaedic prosthesis implantation positioning instrument, single-use
DRIVER 2342280L 4.75 FAS L
MEDTRONIC SOFAMOR DANEK, INC.
2342280L
In Commercial Distribution

  • 00613994649751 ()


  • Bone tap, reusable
DRIVER 2342280S 4.75 FAS S
MEDTRONIC SOFAMOR DANEK, INC.
2342280S
In Commercial Distribution

  • 00613994649737 ()


  • Bone tap, reusable
DRIVER 2342375M MPA M
MEDTRONIC SOFAMOR DANEK, INC.
2342375M
Not in Commercial Distribution

  • 00613994649713 ()


  • Surgical screwdriver, reusable
DRIVER 2342393M POST M
MEDTRONIC SOFAMOR DANEK, INC.
2342393M
In Commercial Distribution

  • 00613994649683 ()


  • Surgical screwdriver, reusable
DRIVER 2342393S POST S
MEDTRONIC SOFAMOR DANEK, INC.
2342393S
In Commercial Distribution

  • 00613994649676 ()


  • Surgical screwdriver, reusable
TAPPER/DRIVER 2393002 TRAY
MEDTRONIC SOFAMOR DANEK, INC.
2393002
In Commercial Distribution

  • 00613994649508 ()


  • Instrument tray, reusable
COUNTER TORQUE 9010000152 ADJUSTBL OPEN
MEDTRONIC SOFAMOR DANEK, INC.
9010000152
In Commercial Distribution

  • 00613994646040 ()


  • Surgical screwdriver, reusable
DRIVER 7578900 SET SCREW RETAINING
MEDTRONIC SOFAMOR DANEK, INC.
7578900
In Commercial Distribution

  • 00613994644831 ()


  • Orthopaedic implant driver
DRIVER X0909041 5.5
MEDTRONIC SOFAMOR DANEK, INC.
X0909041
In Commercial Distribution

  • 00613994681027 ()


  • Surgical screwdriver, reusable
DRIVER 9734259 ORANGE ASSY
MEDTRONIC NAVIGATION, INC.
9734259
In Commercial Distribution

  • 00613994671882 ()


  • Multi-purpose stereotactic surgery system
DRIVER 9734228 GRAY ASSY
MEDTRONIC NAVIGATION, INC.
9734228
In Commercial Distribution

  • 00613994671820 ()


  • Stereotactic surgery system probe, reusable
DRIVER X0809009 MAS EXTRA SHORT
MEDTRONIC SOFAMOR DANEK, INC.
X0809009
In Commercial Distribution

  • 00613994671646 ()


  • Surgical screwdriver, reusable
DRIVER 2342280M 4.75 FAS M
MEDTRONIC SOFAMOR DANEK, INC.
2342280M
In Commercial Distribution

  • 00613994649744 ()


  • Surgical screwdriver, reusable
DRIVER 2342375L MPA L
MEDTRONIC SOFAMOR DANEK, INC.
2342375L
In Commercial Distribution

  • 00613994649720 ()


  • Surgical screwdriver, reusable
DRIVER 2342393L POST L
MEDTRONIC SOFAMOR DANEK, INC.
2342393L
In Commercial Distribution

  • 00613994649690 ()


  • Surgical screwdriver, reusable
COUNTER TORQUE 9010000153 ADJUSTABLE
MEDTRONIC SOFAMOR DANEK, INC.
9010000153
In Commercial Distribution

  • 00613994646057 ()


  • Surgical screwdriver, reusable
DRIVER 5484111 4.75 LOCK SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
5484111
In Commercial Distribution

  • 00613994634054 ()


  • Surgical screwdriver, reusable
SCREWDRIVER X1009576 3.5 MAS
MEDTRONIC SOFAMOR DANEK, INC.
X1009576
In Commercial Distribution

  • 00613994718129 ()


  • Surgical screwdriver, reusable
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