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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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
M8 MAS DRIVER WITH PIN
MEDTRONIC SOFAMOR DANEK, INC.
X1202005
In Commercial Distribution

  • 00721902711183 ()


  • Orthopaedic implant driver
INSTRUMENT 8361027 SCRW REMOVAL DRIVER3D
MEDTRONIC SOFAMOR DANEK, INC.
8361027
In Commercial Distribution

  • 00721902707537 ()


  • Orthopaedic implant driver
SHORT FINAL PLUG TIGHTENER
MEDTRONIC SOFAMOR DANEK, INC.
X0103004
In Commercial Distribution

  • 00721902697500 ()


  • Surgical screwdriver, reusable
QUICK CONNECT T20 DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X0103001
In Commercial Distribution

  • 00721902696831 ()


  • Orthopaedic implant driver
INSTRUMENT 9339031 HEX DRIVER QC
MEDTRONIC SOFAMOR DANEK, INC.
9339031
In Commercial Distribution

  • 00721902692598 ()


  • Surgical drill guide, reusable
SCREWDRIVER
MEDTRONIC SOFAMOR DANEK, INC.
Y853-630
In Commercial Distribution

  • 00721902683268 ()


  • Surgical screwdriver, reusable
SCREWDRIVER 961584 SURETRAK2
MEDTRONIC NAVIGATION, INC.
961584
In Commercial Distribution

  • 00721902672316 ()


  • 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
DRIVER 8110535 80LB LIMIT 7/32 INCH
MEDTRONIC SOFAMOR DANEK, INC.
8110535
In Commercial Distribution

  • 00721902738838 ()


  • Surgical screwdriver, reusable
ATL MODIFIED LOCKSCREW DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X0203003
In Commercial Distribution

  • 00721902737619 ()


  • Orthopaedic implant driver
ZEP SCREWDRIVER 300SS
MEDTRONIC SOFAMOR DANEK, INC.
X0103321
In Commercial Distribution

  • 00721902725449 ()


  • Orthopaedic implant driver
The Explant Kit package contains 2 Lead Caps and 1 Torque Driver.
Neuropace, Inc.
EX-01-K
In Commercial Distribution

  • 00855547005410 ()


  • Brain-responsive electrical stimulation system
The Connector Cover package contains 1 Connector Cover, 2 Connector Plugs, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
CC-01-K
In Commercial Distribution

  • 00855547005397 ()


  • Brain-responsive electrical stimulation system
The Craniectomy Template package contains 1 Craniectomy Template, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
CT-01-K
In Commercial Distribution

  • 00855547005380 ()


  • Brain-responsive electrical stimulation system
The Ferrule package contains 1 Ferrule, 1 Ferrule Clamp and 1 Torque Driver.
Neuropace, Inc.
F-01-K
In Commercial Distribution

  • 00855547005373 ()


  • Brain-responsive electrical stimulation system
The NeuroPace® RNS® Neurostimulator package contains 1 RNS® Neurostimulator, 1 Connector Cover, 1 Ferrule, 1 Ferrule Clamp, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
RNS-320-K
In Commercial Distribution

  • 00855547005366 ()


  • Brain-responsive electrical stimulation system
The NeuroPace® RNS® Neurostimulator package contains 1 RNS® Neurostimulator, 1 Connector Cover, 1 Ferrule, 1 Ferrule Clamp, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
RNS-320-K
In Commercial Distribution

  • 00855547005267 ()


  • Brain-responsive electrical stimulation system
The Burr Hole Cover package contains 1 Burr Hole Cover.
Neuropace, Inc.
8110
In Commercial Distribution

  • 00855547005205 ()

  • Compatible with a 1.3 mm lead. Requires three 1.5 to 1.8 mm bone screws.
  • Outer Diameter: 14 Millimeter


  • Cranial bur hole cover
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
The Ferrule package contains 1 Ferrule, 1 Ferrule Clamp and 1 Torque Driver.
Neuropace, Inc.
F-01-K
In Commercial Distribution

  • 00855547005175 ()


  • Brain-responsive electrical stimulation system
The Craniectomy Template package contains 1 Craniectomy Template, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
CT-01-K
In Commercial Distribution

  • 00855547005168 ()


  • Brain-responsive electrical stimulation system
The Connector Cover package contains 1 Connector Cover, 2 Connector Plugs, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
CC-01-K
In Commercial Distribution

  • 00855547005151 ()


  • Brain-responsive electrical stimulation system
The NeuroPace® RNS® Neurostimulator package contains 1 RNS® Neurostimulator, 1 Connector Cover, 1 Ferrule, 1 Ferrule Clamp, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
RNS-300M-K
In Commercial Distribution

  • 00855547005120 ()


  • Brain-responsive electrical stimulation system
Guidewire Driver
Si-Bone Inc.
501323
In Commercial Distribution

  • 00855369008705 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Torx Driver
Si-Bone Inc.
501243
In Commercial Distribution

  • 00855369008699 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Nav Adapter - Driver
Si-Bone Inc.
400291
In Commercial Distribution

  • 00855369008682 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Driver Sleeve 1
Si-Bone Inc.
400248
In Commercial Distribution

  • 00855369008521 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Driver Sleeve 2
Si-Bone Inc.
400262
In Commercial Distribution

  • 00855369008514 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Torx Driver, Cannulated
Si-Bone Inc.
501129
In Commercial Distribution

  • 00855369008484 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
AdvantageRib X-Driver, AO Quick-Connect
SIG MEDICAL CORP.
323.0075
In Commercial Distribution

  • 00854865007403 ()
323.0075

  • Surgical screwdriver, reusable
SF M6 Bolt Driver
Clearpoint Neuro, Inc.
NGS-BD-M6
In Commercial Distribution

  • 00850359007584 ()
NGS-BD-M6

  • Neurological stereotactic surgery system
The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
6.5 Headed Implant Prep Kit Including Reamer
In Commercial Distribution

  • 00850310006892 ()
1456-6565

  • Surgical countersink, single-use
  • Surgical instrument handle, non-torque-limiting
  • Fluted surgical drill bit, single-use
  • Surgical screwdriver, single-use
  • Surgical depth gauge, single-use
  • Orthopaedic intraoperative positioning pin, single-use
The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
5.0 Headed Implant Prep Kit Including Reamer
In Commercial Distribution

  • 00850310006885 ()
1456-5050

  • Surgical depth gauge, single-use
  • Surgical screwdriver, single-use
  • Fluted surgical drill bit, single-use
  • Surgical instrument handle, non-torque-limiting
  • Surgical countersink, single-use
  • Orthopaedic intraoperative positioning pin, single-use
The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
3.0 Headless Implant Prep Kit Including Reamer
In Commercial Distribution

  • 00850310006878 ()
1456-1408

  • Surgical countersink, single-use
  • Surgical instrument handle, non-torque-limiting
  • Fluted surgical drill bit, single-use
  • Surgical depth gauge, single-use
  • Surgical screwdriver, single-use
  • Orthopaedic intraoperative positioning pin, single-use
The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
4.0 Headed Implant Prep Kit Including Reamer
In Commercial Distribution

  • 00850310006861 ()
1456-4040

  • Surgical screwdriver, single-use
  • Surgical depth gauge, single-use
  • Fluted surgical drill bit, single-use
  • Surgical instrument handle, non-torque-limiting
  • Surgical countersink, single-use
  • Orthopaedic intraoperative positioning pin, single-use
The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
3.0 Headed Implant Prep Kit Including Reamer
In Commercial Distribution

  • 00850310006854 ()
1456-3030

  • Surgical depth gauge, single-use
  • Surgical screwdriver, single-use
  • Surgical countersink, single-use
  • Surgical instrument handle, non-torque-limiting
  • Fluted surgical drill bit, single-use
  • Orthopaedic intraoperative positioning pin, single-use
Intraosseous Fixation Implant to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe, mallet toe and inter-digital fusions.
CROSSROADS EXTREMITY SYSTEMS
Inserter
In Commercial Distribution

  • 00850310006489 ()

  • Driver for 3.0mm CrossTIE Implant
4200-0000

  • Orthopaedic implant driver
CrossRoads™ Bone Screw System is used for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the bone screw.
CROSSROADS EXTREMITY SYSTEMS
Snap-Off Driver - Sterile
In Commercial Distribution

  • 00850310006410 ()
1456-0026

  • Surgical screwdriver, single-use
Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe, mallet toe and inter-digital fusions.
CROSSROADS EXTREMITY SYSTEMS
1456-0018
In Commercial Distribution

  • 00850310006397 ()
1456-0018

  • Orthopaedic inorganic implant inserter/extractor, reusable
Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe, mallet toe and inter-digital fusions.
CROSSROADS EXTREMITY SYSTEMS
1456-0015
In Commercial Distribution

  • 00850310006380 ()
1456-0015

  • Orthopaedic inorganic implant inserter/extractor, reusable
3.5MM HEX U-JOINT DRIVER
Conformis, Inc.
1080-561
In Commercial Distribution

  • 00850268007552 ()

  • Outer Diameter: 3.5 Millimeter


  • Orthopaedic prosthesis implantation positioning instrument, reusable
DRIVER, RIGID, 3.5MM HEX
Conformis, Inc.
1080-560
In Commercial Distribution

  • 00850268007545 ()

  • Outer Diameter: 3.5 Millimeter


  • Orthopaedic prosthesis implantation positioning instrument, reusable
TRAUMA KIT, 1211-1X X-LARGE RING, 1206-33 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6X4
In Commercial Distribution

  • 00650551094616 ()
1211-6X4

  • Cervical spine immobilization system, single-use
TRAUMA KIT, 1211-1X X-LARGE RING, 1206-32 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6X3
In Commercial Distribution

  • 00650551094609 ()
1211-6X3

  • Cervical spine immobilization system, single-use
TRAUMA KIT, 1211-1X X-LARGE RING, 1206-20 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6X1
In Commercial Distribution

  • 00650551094593 ()
1211-6X1

  • Cervical spine immobilization system, single-use
TRAUMA KIT, 1211-1S SMALL RING, 1206-33 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6S4
In Commercial Distribution

  • 00650551094586 ()
1211-6S4

  • Cervical spine immobilization system, single-use
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