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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4.25mm dia.12mm long fixed screw Implant. The Quantum Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PCP-425-12F
In Commercial Distribution

  • 90810005669057 ()

  • Outer Diameter: 4.25 Millimeter
  • Length: 12 Millimeter


  • Intervertebral-body internal spinal fixation system
Rod, Lordotic 5.5X95mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion5
NVISION BIOMEDICAL TECHNOLOGIES, INC.
L-01-095
In Commercial Distribution

  • 00810005667241 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 95 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
The Neurolutions System is a Brain-Computer-Interface (BCI) device developed for rehabilitation of upper extremity disability for chronic stroke patients. The device consists of the Neurolutions robotic handpiece, a biometric headset, and a Windows-based tablet computer. The Neurolutions System provides upper extremity rehabilitation using three separate modes: the main mode of therapy is referred to as the BCI or ‘thought’ mode, in which the patient’s hand is opened or closed by the Orthosis based on brain-signals received from the biometric headset; the second mode is referred to as a ‘volitional’ mode in which a patient actively opens and closes their hand with the System enabling independent range of motion; the third is a continuous passive motion (CPM) mode in which the System simply moves the patient’s hand passively through a comfortable range of motion in a repetitive fashion.
Neurolutions, Inc
FGS-1000-02
In Commercial Distribution

  • 00850005539025 ()


  • Neuro-controlled joint movement exoskeleton
The Neurolutions System is a Brain-Computer-Interface (BCI) device developed for rehabilitation of upper extremity disability for chronic stroke patients. The device consists of the Neurolutions robotic handpiece, a biometric headset, and a Windows-based tablet computer. The Neurolutions System provides upper extremity rehabilitation using three separate modes: the main mode of therapy is referred to as the BCI or ‘thought’ mode, in which the patient’s hand is opened or closed by the Orthosis based on brain-signals received from the biometric headset; the second mode is referred to as a ‘volitional’ mode in which a patient actively opens and closes their hand with the System enabling independent range of motion; the third is a continuous passive motion (CPM) mode in which the System simply moves the patient’s hand passively through a comfortable range of motion in a repetitive fashion.
Neurolutions, Inc
FGS-1000-01
In Commercial Distribution

  • 00850005539018 ()


  • Neuro-controlled joint movement exoskeleton
Omnia Medical VBR, Graft Packing Block
OMNIA MEDICAL, LLC
06-5V-PAC1
In Commercial Distribution

  • 00843511100421 ()
06-5V-PAC1

  • Bone graft packing block
Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0002-02
In Commercial Distribution

  • 03760178394857 ()


  • General internal orthopaedic fixation system implantation kit
Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0002
In Commercial Distribution

  • 03760178394840 ()


  • General internal orthopaedic fixation system implantation kit
Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0001
In Commercial Distribution

  • 03760178394833 ()


  • General internal orthopaedic fixation system implantation kit
Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-SQA-0025
In Commercial Distribution

  • 03760178394826 ()


  • General internal orthopaedic fixation system implantation kit
Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-CPL-0002
In Commercial Distribution

  • 03760178394802 ()


  • General internal orthopaedic fixation system implantation kit
Origin Stem, Coxa Vara Size 18
PAXEON RECONSTRUCTION LLC
PR111-18-1804
In Commercial Distribution

  • 08177570200696 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 18 Collared
PAXEON RECONSTRUCTION LLC
PR111-18-1802
In Commercial Distribution

  • 08177570200689 ()


  • Coated hip femur prosthesis, modular
Origin Stem, High Offset Size 18
PAXEON RECONSTRUCTION LLC
PR111-18-1801
In Commercial Distribution

  • 08177570200672 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 18
PAXEON RECONSTRUCTION LLC
PR111-18-1800
In Commercial Distribution

  • 08177570200665 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 16
PAXEON RECONSTRUCTION LLC
PR111-18-1604
In Commercial Distribution

  • 08177570200658 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 16 Collared
PAXEON RECONSTRUCTION LLC
PR111-18-1602
In Commercial Distribution

  • 08177570200641 ()


  • Coated hip femur prosthesis, modular
Origin Stem, High Offset Size 16
PAXEON RECONSTRUCTION LLC
PR111-18-1601
In Commercial Distribution

  • 08177570200634 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 16
PAXEON RECONSTRUCTION LLC
PR111-18-1600
In Commercial Distribution

  • 08177570200627 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 15
PAXEON RECONSTRUCTION LLC
PR111-18-1504
In Commercial Distribution

  • 08177570200610 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 15 Collared
PAXEON RECONSTRUCTION LLC
PR111-18-1502
In Commercial Distribution

  • 08177570200603 ()


  • Coated hip femur prosthesis, modular
Origin Stem, High Offset Size 15
PAXEON RECONSTRUCTION LLC
PR111-18-1501
In Commercial Distribution

  • 08177570200597 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 15
PAXEON RECONSTRUCTION LLC
PR111-18-1500
In Commercial Distribution

  • 08177570200580 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 14
PAXEON RECONSTRUCTION LLC
PR111-18-1404
In Commercial Distribution

  • 08177570200573 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 14 Collared
PAXEON RECONSTRUCTION LLC
PR111-18-1402
In Commercial Distribution

  • 08177570200566 ()


  • Coated hip femur prosthesis, modular
Origin Stem, High Offset Size 14
PAXEON RECONSTRUCTION LLC
PR111-18-1401
In Commercial Distribution

  • 08177570200559 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 14
PAXEON RECONSTRUCTION LLC
PR111-18-1400
In Commercial Distribution

  • 08177570200542 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 13
PAXEON RECONSTRUCTION LLC
PR111-18-1304
In Commercial Distribution

  • 08177570200535 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 13 Collared
PAXEON RECONSTRUCTION LLC
PR111-18-1302
In Commercial Distribution

  • 08177570200528 ()


  • Coated hip femur prosthesis, modular
Origin Stem, High Offset Size 13
PAXEON RECONSTRUCTION LLC
PR111-18-1301
In Commercial Distribution

  • 08177570200511 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 13
PAXEON RECONSTRUCTION LLC
PR111-18-1300
In Commercial Distribution

  • 08177570200504 ()


  • Coated hip femur prosthesis, modular
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