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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 - 90810005669125

3.75mm dia.14mm long variable 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-375-14V
In Commercial Distribution

  • 90810005669125 ()

  • Outer Diameter: 3.75 Millimeter
  • Length: 14 Millimeter


  • Spinal bone screw, non-bioabsorbable

Quantum - 90810005669064

4.25mm dia.14mm 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-425-14F
In Commercial Distribution

  • 90810005669064 ()

  • Outer Diameter: 4.25 Millimeter
  • Length: 14 Millimeter


  • Spinal bone screw, non-bioabsorbable

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


  • Spinal bone screw, non-bioabsorbable

QUANTUM - 33701337605668

QUANTUM CORNER CHISEL FOR TIBIAL PREPARATION
IN2BONES
M05 01241
In Commercial Distribution

  • 33701337605668 ()
M05 01241

  • Orthopaedic chisel

QUANTUM - 03701337605520

QUANTUM Tibial Implant Guide
IN2BONES
M05 00731
In Commercial Distribution

  • 03701337605520 ()

  • Length: 28 Millimeter
  • Height: 31.8 Millimeter
M05 00731

  • Orthopaedic instrument surgical connector

QUANTUM - 03701337601157

QUANTUM Resection Guide For Talar Chamfer S6
IN2BONES
M05 01031
In Commercial Distribution

  • 03701337601157 ()

  • Length: 72.69 Millimeter
  • Width: 36.26 Millimeter
M05 01031

  • Osteotomy guide, reusable

AI Surgical Kit - 08806388286225

No Description
Megagen Implant Co. Ltd
KAISS3000
In Commercial Distribution

  • 08806388286225 ()
KAISS3000

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable

NA - 04546540075222

Quantum Drill Irrigation Clip
STRYKER CORPORATION
5100020200
In Commercial Distribution

  • 04546540075222 ()
5100-020-200

  • Sawing power tool attachment, oscillating

Sonnenschein Nasal Speculum - 00192896108783

Sonnenschein Nasal Speculum Quantum
SONTEC INSTRUMENTS, INC.
465-320Q
In Commercial Distribution

  • 00192896108783 ()

  • Length: 6 Inch
465-320Q

  • Nasal speculum, reusable

Russian Tissue Forceps - 00192896106659

RUSSIAN TISSUE FORCEPS QUANTUM
SONTEC INSTRUMENTS, INC.
136-773Q
In Commercial Distribution

  • 00192896106659 ()

  • Length: 8 Inch


  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
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