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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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Quantum - 90810005669057

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

Omnia Medical PsiF - 00843511100636

PsiF Post Packer (Long Impactor) Instrument
OMNIA MEDICAL, LLC
01-01-0010
In Commercial Distribution

  • 00843511100636 ()
01-01-0010

  • Bone graft packing block

Omnia Medical VBR - 00843511100421

Omnia Medical VBR, Graft Packing Block
OMNIA MEDICAL, LLC
06-5V-PAC1
In Commercial Distribution

  • 00843511100421 ()
06-5V-PAC1

  • Bone graft packing block

OrthoMedFlex - M7161124411180

Origin R Broach Size 18
ORTHOMEDFLEX LLC
112-44-1118
In Commercial Distribution

  • M7161124411180 ()


  • Orthopaedic broach

OrthoMedFlex - M7161124411160

Origin R Broach Size 16
ORTHOMEDFLEX LLC
112-44-1116
In Commercial Distribution

  • M7161124411160 ()


  • Orthopaedic broach

OrthoMedFlex - M7161124411150

Origin R Broach Size 15
ORTHOMEDFLEX LLC
112-44-1115
In Commercial Distribution

  • M7161124411150 ()


  • Orthopaedic broach

OrthoMedFlex - M7161124411140

Origin R Broach Size 14
ORTHOMEDFLEX LLC
112-44-1114
In Commercial Distribution

  • M7161124411140 ()


  • Orthopaedic broach

OrthoMedFlex - M7161124411130

Origin R Broach Size 13
ORTHOMEDFLEX LLC
112-44-1113
In Commercial Distribution

  • M7161124411130 ()


  • Orthopaedic broach

OrthoMedFlex - M7161124411120

Origin R Broach Size 12
ORTHOMEDFLEX LLC
112-44-1112
In Commercial Distribution

  • M7161124411120 ()


  • Orthopaedic broach

OrthoMedFlex - M7161124411110

Origin R Broach Size 11
ORTHOMEDFLEX LLC
112-44-1111
In Commercial Distribution

  • M7161124411110 ()


  • Orthopaedic broach
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