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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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VSP System - 00816847020862

A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.
3D SYSTEMS, INC.
Iliac Crest Marking Guide
In Commercial Distribution

  • 00816847020862 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020855

A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.
3D SYSTEMS, INC.
Iliac Crest Cutting Guide
In Commercial Distribution

  • 00816847020855 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020848

A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.
3D SYSTEMS, INC.
Maxilla Marking Guide
In Commercial Distribution

  • 00816847020848 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020831

A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.
3D SYSTEMS, INC.
Maxilla Cutting Guide
In Commercial Distribution

  • 00816847020831 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020824

A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.
3D SYSTEMS, INC.
Mandible Marking Guide
In Commercial Distribution

  • 00816847020824 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020817

A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.
3D SYSTEMS, INC.
Mandible Cutting Guide
In Commercial Distribution

  • 00816847020817 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020800

A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.
3D SYSTEMS, INC.
Fibula Marking Guide
In Commercial Distribution

  • 00816847020800 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020572

A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes
3D SYSTEMS, INC.
LeFort Drilling Guide
In Commercial Distribution

  • 00816847020572 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020565

A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.
3D SYSTEMS, INC.
Final Palatal Splint (No Dentition Included)
In Commercial Distribution

  • 00816847020565 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020558

A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.
3D SYSTEMS, INC.
Intermediate Sandwich Surgical Splint
In Commercial Distribution

  • 00816847020558 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020541

A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.
3D SYSTEMS, INC.
Final Surgical Splint
In Commercial Distribution

  • 00816847020541 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020534

A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.
3D SYSTEMS, INC.
Intermediate Surgical Splint
In Commercial Distribution

  • 00816847020534 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020527

A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.
3D SYSTEMS, INC.
Initial Surgical Splint
In Commercial Distribution

  • 00816847020527 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020510

A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.
3D SYSTEMS, INC.
Surgical Splint
In Commercial Distribution

  • 00816847020510 ()


  • Custom-made orthopaedic/craniofacial surgical guide

DJO SURGICAL - 00888912127165

SCREW DRIVER, HEX HEAD
Encore Medical, L.P.
801-01-042
In Commercial Distribution

  • 00888912127165 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

DJO SURGICAL - 00888912126250

DRIVER, HEADED PIN EPIK
Encore Medical, L.P.
800-03-028
In Commercial Distribution

  • 00888912126250 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

DJO SURGICAL - 00888912123495

DRIVER,HEX REVISION
DJO, LLC
800-01-263
In Commercial Distribution

  • 00888912123495 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

INnate Instrument Kit - B487EXINN9145000

INnate Sterile Instrument Kit The kit contains two guide wires, one cannulated drill, and one cannulated driver.
Exsomed Corporation
EXINN914500
Not in Commercial Distribution

  • B487EXINN9145000 ()
EXINN914500

  • Orthopaedic implant driver
  • Orthopaedic guidewire, single-use
  • Cannulated surgical drill bit, single-use
  • Surgical depth gauge, single-use

INnate Instrument Kit - B487EXINN9136000

INnate Sterile Instrument Kit The kit contains two guide wires, one cannulated drill, and one cannulated driver.
Exsomed Corporation
EXINN913600
Not in Commercial Distribution

  • B487EXINN9136000 ()
EXINN913600

  • Orthopaedic implant driver
  • Orthopaedic guidewire, single-use
  • Cannulated surgical drill bit, single-use
  • Surgical depth gauge, single-use

NanoPhix Instrument Kit - B487EXINN9115000

NanoPhix sterile instrument kit. The kit contains 1 depth gauge, 2 guide wires, 1 driver.
Exsomed Corporation
EXINN911500
Not in Commercial Distribution

  • B487EXINN9115000 ()
EXINN911500

  • Surgical depth gauge, single-use
  • Orthopaedic guidewire, single-use
  • Orthopaedic implant driver

InFrame Instrument Kit - B487EXINF9120000

InFrame sterile instrument kit. The kit contains two step guide wires, one cannulated drill, one depth gauge
Exsomed Corporation
EXINF912000
Not in Commercial Distribution

  • B487EXINF9120000 ()
EXINF912000

  • Surgical depth gauge, single-use
  • Orthopaedic guidewire, single-use
  • Orthopaedic implant driver

ArrowPhix System - B487EXARR9025260

ArrowPhix Compression Screw System The System includes the implant, two guide wires, and one driver.
Exsomed Corporation
EXARR902526
Not in Commercial Distribution

  • B487EXARR9025260 ()

  • Length: 26 Millimeter
  • Outer Diameter: 2.5 Millimeter
EXARR902526

  • Orthopaedic implant driver
  • Orthopaedic guidewire, single-use
  • Orthopaedic bone screw, non-bioabsorbable, sterile

ArcPhix System - B487EXARC9030280

ArcPhix Compression Screw System The system includes the implant, two guide wires, one cannulated drill, and a driver.
Exsomed Corporation
EXARC903028
Not in Commercial Distribution

  • B487EXARC9030280 ()

  • Length: 28 Millimeter
  • Outer Diameter: 3.0 Millimeter
EXARC903028

  • Orthopaedic implant driver
  • Orthopaedic guidewire, single-use
  • Cannulated surgical drill bit, single-use
  • Orthopaedic bone screw (non-sliding)

360CAS - B432360CAS00760

4mm Hex Driver Long
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0076
In Commercial Distribution

  • B432360CAS00760 ()


  • Robotic surgical navigation system application software

360CAS - B432360CAS00680

CAS Flex Driver
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0068
In Commercial Distribution

  • B432360CAS00680 ()


  • Robotic surgical navigation system application software

MSI - B4198101060

No Description
Modern Surgical Instruments LLC
81-0106
In Commercial Distribution

  • B4198101060 ()


  • Surgical screwdriver, reusable

MSI - B4192710700

No Description
Modern Surgical Instruments LLC
27.10.70
In Commercial Distribution

  • B4192710700 ()


  • Surgical mallet

GEO Staple System - B471240000020

Staple Tamp, Large
GRAMERCY EXTREMITY ORTHOPEDICS LLC
24000002
In Commercial Distribution

  • B471240000020 ()


  • Orthopaedic bone staple driver

GEO Staple System - B471240000010

Staple Tamp, Small
GRAMERCY EXTREMITY ORTHOPEDICS LLC
24000001
In Commercial Distribution

  • B471240000010 ()


  • Orthopaedic bone staple driver

GEO Bone Screw System - B471212502300

Drill Bit 5.0mmx230mm ZH Cannulated
GRAMERCY EXTREMITY ORTHOPEDICS LLC
21250230
In Commercial Distribution

  • B471212502300 ()

  • Outer Diameter: 5.0 Millimeter
  • Length: 230 Millimeter


  • Cannulated surgical drill bit, single-use
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