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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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Implant: 2.5mm dia x 16mm Fixation Screw Ti. The Trigon HA Stand-Alone Wedge Fixation System is a family of wedges used for angular correction of small bones of the foot. The HA PEEK wedges w/ tantalum markers are provided in multiple footprint and thickness designs, and the titanium bone screws are available in multiple lengths to accommodate variations in patient anatomy.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WSC-25-16
In Commercial Distribution

  • 00810005668224 ()

  • Outer Diameter: 2.5 Millimeter
  • Length: 16 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Implant: 2.5mm dia x 14mm Fixation Screw Ti. The Trigon HA Stand-Alone Wedge Fixation System is a family of wedges used for angular correction of small bones of the foot. The HA PEEK wedges w/ tantalum markers are provided in multiple footprint and thickness designs, and the titanium bone screws are available in multiple lengths to accommodate variations in patient anatomy.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WSC-25-14
In Commercial Distribution

  • 00810005668217 ()

  • Outer Diameter: 2.5 Millimeter
  • Length: 14 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Implant: 2.5mm dia x 12mm Fixation Screw Ti. The Trigon HA Stand-Alone Wedge Fixation System is a family of wedges used for angular correction of small bones of the foot. The HA PEEK wedges w/ tantalum markers are provided in multiple footprint and thickness designs, and the titanium bone screws are available in multiple lengths to accommodate variations in patient anatomy.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WSC-25-12
In Commercial Distribution

  • 00810005668200 ()

  • Outer Diameter: 2.5 Millimeter
  • Length: 12 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Implant: 2.5mm dia x 10mm Fixation Screw Ti. The Trigon HA Stand-Alone Wedge Fixation System is a family of wedges used for angular correction of small bones of the foot. The HA PEEK wedges w/ tantalum markers are provided in multiple footprint and thickness designs, and the titanium bone screws are available in multiple lengths to accommodate variations in patient anatomy.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WSC-25-10
In Commercial Distribution

  • 00810005668194 ()

  • Outer Diameter: 2.5 Millimeter
  • Length: 10 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The PACS Scan Mobile client is an application for mobile devices that can used to easily capture images and videos and send them to patient studies on DICOM archives. The user queries and retrieves a patient study from a worklist, or creates a new patient record. The user may then take clinical photos and/or videos to send to the patient record. Photos may be manipulated (crop and rotate) and annotated prior to sending. Videos may not be altered prior to sending. Unwanted images may be deleted prior to sending. The user may also add a series description to the study. Typical users of the PACS Scan Mobile application are trained medical professionals, including but not limited to clinicians, technologists, assistants and lay persons. PSM is not intended for diagnostic use.
HYLAND LLC
3.0
In Commercial Distribution

  • 00850677007143 ()
PSM3.0

  • Clinical information system web-based application software
Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, 100 mm Length The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F136. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
AISP-2808-7510
In Commercial Distribution

  • 00840185314277 ()
2808-7510

  • Bone-screw internal spinal fixation system, non-sterile
Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, 95 mm Length The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F136. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
AISP-2808-7595
In Commercial Distribution

  • 00840185314260 ()
2808-7595

  • Bone-screw internal spinal fixation system, non-sterile
Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, 90 mm Length The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F136. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
AISP-2808-7590
In Commercial Distribution

  • 00840185314253 ()
2808-7590

  • Bone-screw internal spinal fixation system, non-sterile
Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, 85 mm Length The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F136. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
AISP-2808-7585
In Commercial Distribution

  • 00840185314246 ()
2808-7585

  • Bone-screw internal spinal fixation system, non-sterile
Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, 80 mm Length The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F136. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
AISP-2808-7580
In Commercial Distribution

  • 00840185314239 ()
2808-7580

  • Bone-screw internal spinal fixation system, non-sterile
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