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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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Spine Instruments - 07630345704269

Setscrew driver SHORT Removable locking handle
Medacta International SA
03.52.10.0714
In Commercial Distribution

  • 07630345704269 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Spine Instruments - 07630345704252

Setscrew driver LONG Removable locking handle
Medacta International SA
03.52.10.0713
In Commercial Distribution

  • 07630345704252 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Spine Instruments - 07630345704245

Quick screw driver - SHORT version Removable locking handle
Medacta International SA
03.52.10.0710
In Commercial Distribution

  • 07630345704245 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Spine Instruments - 07630345704238

Quick screw driver - LONG version Removable locking handle
Medacta International SA
03.52.10.0709
In Commercial Distribution

  • 07630345704238 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Spine Instruments - 07630345701565

Alif Straight tapered driver
Medacta International SA
03.30.10.1970
In Commercial Distribution

  • 07630345701565 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

MectaLock PEEK Suture Anchor - 07630345701466

MectaLock PEEK - Ø6.5 - Short driver
Medacta International SA
05.10.006
In Commercial Distribution

  • 07630345701466 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable

MectaLock PEEK Suture Anchor - 07630345701459

MectaLock PEEK - Ø5.5 - Short driver
Medacta International SA
05.10.005
In Commercial Distribution

  • 07630345701459 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable

MectaLock PEEK Suture Anchor - 07630345701442

MectaLock PEEK - Ø4.5 - Short driver
Medacta International SA
05.10.004
In Commercial Distribution

  • 07630345701442 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable

VSP System, VSP Cranial - 00816847021463

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Resected Anatomical Model
In Commercial Distribution

  • 00816847021463 ()


  • Custom-made organ/bone anatomy model

VSP System, VSP Cranial - 00816847021456

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Resected Full Skull Model
In Commercial Distribution

  • 00816847021456 ()


  • Custom-made organ/bone anatomy model

VSP System, VSP Cranial - 00816847021364

Reusable accessory Cutting insert
3D SYSTEMS, INC.
Metal Slot (45mm)
In Commercial Distribution

  • 00816847021364 ()

  • Length: 45 Millimeter


  • Osteotomy guide, reusable

VSP System, VSP Cranial - 00816847021357

Reusable accessory Cutting insert
3D SYSTEMS, INC.
Metal Slot (40mm)
In Commercial Distribution

  • 00816847021357 ()

  • Length: 40 Millimeter


  • Osteotomy guide, reusable

VSP System, VSP Cranial - 00816847021340

Reusable accessory Cutting insert
3D SYSTEMS, INC.
Metal Slot (35mm)
In Commercial Distribution

  • 00816847021340 ()

  • Length: 35 Millimeter


  • Osteotomy guide, reusable

VSP System, VSP Cranial - 00816847021333

Reusable accessory Cutting insert
3D SYSTEMS, INC.
Metal Slot (25mm)
In Commercial Distribution

  • 00816847021333 ()

  • Length: 25 Millimeter


  • Osteotomy guide, reusable

VSP System, VSP Cranial - 00816847021326

Reusable accessory drill guide
3D SYSTEMS, INC.
Drill Guide (1.1 mm & 2.3 mm Screws)
In Commercial Distribution

  • 00816847021326 ()

  • Outer Diameter: 1.0 Millimeter


  • Surgical drill guide, reusable

VSP System, VSP Cranial - 00816847021319

Reusable accessory drill guide
3D SYSTEMS, INC.
Drill Guide (1mm Pre-Drill)
In Commercial Distribution

  • 00816847021319 ()

  • Outer Diameter: 1.0 Millimeter


  • Surgical drill guide, reusable

VSP System, VSP Cranial - 00816847021302

Reusable accessory drill guide
3D SYSTEMS, INC.
Drill Guide (2.3 mm & 2.7 mm Screws)
In Commercial Distribution

  • 00816847021302 ()

  • Outer Diameter: 2.3 Millimeter


  • Surgical drill guide, reusable

VSP System, VSP Cranial - 00816847021296

Reusable accessory drill guide
3D SYSTEMS, INC.
Drill Guide (2.0 mm Screws)
In Commercial Distribution

  • 00816847021296 ()

  • Outer Diameter: 2.0 Millimeter


  • Surgical drill guide, reusable

VSP System, VSP Cranial - 00816847021289

A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize patient anatomy. Model may also be used to pre-contour off-the-shelf implants.
3D SYSTEMS, INC.
Implant Template
In Commercial Distribution

  • 00816847021289 ()


  • Surgical implant template, single-use

VSP System, VSP Cranial - 00816847021272

A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize patient anatomy. Model may also be used to pre-contour off-the-shelf implants.
3D SYSTEMS, INC.
Bone Graft Template
In Commercial Distribution

  • 00816847021272 ()


  • Surgical implant template, single-use

VSP System, VSP Cranial - 00816847021265

A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize patient anatomy. Model may also be used to pre-contour off-the-shelf implants.
3D SYSTEMS, INC.
Graft Pre-Contouring Template
In Commercial Distribution

  • 00816847021265 ()


  • Surgical implant template, single-use

VSP System - 00816847021258

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Resected Mandible Model
In Commercial Distribution

  • 00816847021258 ()


  • Custom-made organ/bone anatomy model

VSP System - 00816847021241

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Resected Maxilla Model
In Commercial Distribution

  • 00816847021241 ()


  • Custom-made organ/bone anatomy model

VSP System - 00816847021234

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Perfected Maxilla/Mandible 2-Piece Model
In Commercial Distribution

  • 00816847021234 ()


  • Custom-made organ/bone anatomy model

VSP System - 00816847021227

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Perfected Maxilla/Mandible 1-Piece Model
In Commercial Distribution

  • 00816847021227 ()


  • Custom-made organ/bone anatomy model

VSP System, VSP Cranial - 00816847021210

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Perfected Full Skull Model
In Commercial Distribution

  • 00816847021210 ()


  • Custom-made organ/bone anatomy model

VSP System - 00816847021203

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Perfected Mandible Model
In Commercial Distribution

  • 00816847021203 ()


  • Custom-made organ/bone anatomy model

VSP System - 00816847021197

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Perfected Maxilla Model
In Commercial Distribution

  • 00816847021197 ()


  • Custom-made organ/bone anatomy model

VSP System, VSP Cranial - 00816847021180

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Perfected Anatomical Model
In Commercial Distribution

  • 00816847021180 ()


  • Custom-made organ/bone anatomy model

VSP System, VSP Cranial - 00816847021173

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Mirrored Anatomical Model
In Commercial Distribution

  • 00816847021173 ()


  • Custom-made organ/bone anatomy model
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