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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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Hex-End Straight Rod 5.5 x 450. The Coral Spinal System consists of a variety of types and sizes of rods, hooks, screws, and connectors. The Coral Spinal System implant components can be rigidly locked into a variety of configurations that can be fit for the individual case. The Coral Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136, ASTM-F-67, and cobalt chrome alloy per ASTM F-1537.
Seaspine Orthopedics Corporation
10-25-0450
In Commercial Distribution

  • 10889981027957 ()

  • 5.5mmx 450mm Rod
10-25-0450

  • Bone-screw internal spinal fixation system, non-sterile
Hex-End Straight Rod 5.5 x 400. The Coral Spinal System consists of a variety of types and sizes of rods, hooks, screws, and connectors. The Coral Spinal System implant components can be rigidly locked into a variety of configurations that can be fit for the individual case. The Coral Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136, ASTM-F-67, and cobalt chrome alloy per ASTM F-1537.
Seaspine Orthopedics Corporation
10-25-0400
In Commercial Distribution

  • 10889981027940 ()

  • 5.5mm x 400mm Rod
10-25-0400

  • Bone-screw internal spinal fixation system, non-sterile
The DataLITE wireless surface EMG sensor gives superb quality of signal and ease of use. With a bandwidth of 5-495 Hz and a built in 1000 gain amplifier and wireless transmitter, surface EMG signals are collected and sent to the Biometrics software for analysis. EMG data can be synchronized real-time with other sensors as part of a complete DataLITE system.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
BIOMETRICS LIMITED
LE230
In Commercial Distribution

  • 05060481690638 ()


  • Electromyography telemetric monitoring system transmitter
The mini Kompressor Compression Screw is a two-piece fixation device intended for the use in the reduction, stabilization, and internal fixation of bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and fix fracture fragments, and is available in a variety of sizes to accommodate various fracture types and sites.
Ascension Orthopedics, Inc.
210326
Not in Commercial Distribution

  • M2482103261 ()
  • 10381780065777 ()

  • 3.6 mm dia x 30 mm L; leading screw 26 mm L
210326

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The mini Kompressor Compression Screw is a two-piece fixation device intended for the use in the reduction, stabilization, and internal fixation of bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and fix fracture fragments, and is available in a variety of sizes to accommodate various fracture types and sites.
Ascension Orthopedics, Inc.
210324
Not in Commercial Distribution

  • M2482103241 ()
  • 10381780065760 ()

  • 3.6 mm dia x 28 mm L; leading screw 24 mm L
210324

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The mini Kompressor Compression Screw is a two-piece fixation device intended for the use in the reduction, stabilization, and internal fixation of bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and fix fracture fragments, and is available in a variety of sizes to accommodate various fracture types and sites.
Ascension Orthopedics, Inc.
210322
Not in Commercial Distribution

  • M2482103221 ()
  • 10381780065753 ()

  • 3.6 mm dia x 26 mm L; leading screw 26 mm L
210322

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The mini Kompressor Compression Screw is a two-piece fixation device intended for the use in the reduction, stabilization, and internal fixation of bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and fix fracture fragments, and is available in a variety of sizes to accommodate various fracture types and sites.
Ascension Orthopedics, Inc.
210320
Not in Commercial Distribution

  • M2482103201 ()
  • 10381780065746 ()

  • 3.6 mm dia x 24 mm L; leading screw 20 mm L
210320

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The mini Kompressor Compression Screw is a two-piece fixation device intended for the use in the reduction, stabilization, and internal fixation of bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and fix fracture fragments, and is available in a variety of sizes to accommodate various fracture types and sites.
Ascension Orthopedics, Inc.
210318
Not in Commercial Distribution

  • M2482103181 ()
  • 10381780065739 ()

  • 3.6 mm dia x 22 mm L; leading screw 18 mm L
210318

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The mini Kompressor Compression Screw is a two-piece fixation device intended for the use in the reduction, stabilization, and internal fixation of bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and fix fracture fragments, and is available in a variety of sizes to accommodate various fracture types and sites.
Ascension Orthopedics, Inc.
210316
Not in Commercial Distribution

  • M2482103161 ()
  • 10381780065722 ()

  • 3.6 mm dia x 20 mm L; leading screw 16 mm L
210316

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The mini Kompressor Compression Screw is a two-piece fixation device intended for the use in the reduction, stabilization, and internal fixation of bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and fix fracture fragments, and is available in a variety of sizes to accommodate various fracture types and sites.
Ascension Orthopedics, Inc.
210314
Not in Commercial Distribution

  • M2482103141 ()
  • 10381780065715 ()

  • 3.6 mm dia x 18 mm L; leading screw 14 mm L
210314

  • Orthopaedic bone screw, non-bioabsorbable, sterile
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