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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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The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody cage with radiographic markers and Titanium (Ti -6Al-4V ELI) fixation screws for cages with screw holes.
Spineup, Inc.
ISRO1214A06CA1
In Commercial Distribution

  • ISRO1214A06CA1 ()

  • Angle: 6 degree
  • Height: 06 Millimeter
  • Width: 14 Millimeter
  • Depth: 12 Millimeter
ISRO1214A06CA1

  • Polymeric spinal interbody fusion cage
The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody cage with radiographic markers and Titanium (Ti -6Al-4V ELI) fixation screws for cages with screw holes.
Spineup, Inc.
ISRO1214A05CB1
In Commercial Distribution

  • ISRO1214A05CB1 ()

  • Width: 14 Millimeter
  • Depth: 12 Millimeter
  • Angle: 6 degree
  • Height: 05 Millimeter
ISRO1214A05CB1

  • Polymeric spinal interbody fusion cage
The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody cage with radiographic markers and Titanium (Ti -6Al-4V ELI) fixation screws for cages with screw holes.
Spineup, Inc.
ISRO1214A04CB1
In Commercial Distribution

  • ISRO1214A04CB1 ()

  • Width: 14 Millimeter
  • Depth: 12 Millimeter
  • Angle: 6 degree
  • Height: 04 Millimeter
ISRO1214A04CB1

  • Polymeric spinal interbody fusion cage
Intuition (also referred to as Aquarius Intuition) is a medical device comprised of two stand-alone software components: a server software backend (Intuition Server) which performs complex image post processing and client viewer software (Intuition Client Viewers) that provides a user interface, enabling the user to view medical image data and associated derived metadata. The Intuition client viewer/server software enables 2D/3D/4D (3D with the dimension of time) image review, volume rendering, communications, storage, reporting, and image post processing. The Intuition software is used with off-the-shelf hardware, including a computer, monitor, keyboard and mouse. Intuition is comprised of six (6) separate client viewers: Intuition Client with Emergency Lung Docker, Intuition Thin Client, Intuition Review, Intuition EMV, Intuition Web Viewer, and Intuition Mobile.
Terarecon Inc.
Intuition04
In Commercial Distribution

  • INTUITION04 ()
Intuition

  • Radiology DICOM image processing application software
No Description
Ritter Implants GmbH & Co. KG
i8-OS-SP6515
In Commercial Distribution

  • I8OSSP6515 ()


  • Screw endosteal dental implant, two-piece
No Description
Ritter Implants GmbH & Co. KG
i8-OS-SP6513
In Commercial Distribution

  • I8OSSP6513 ()


  • Screw endosteal dental implant, two-piece
No Description
Ritter Implants GmbH & Co. KG
i8-OS-SP6511
In Commercial Distribution

  • I8OSSP6511 ()


  • Screw endosteal dental implant, two-piece
No Description
Ritter Implants GmbH & Co. KG
i8-OS-SP6510
In Commercial Distribution

  • I8OSSP6510 ()


  • Screw endosteal dental implant, two-piece
No Description
Ritter Implants GmbH & Co. KG
i8-OS-SP6508
In Commercial Distribution

  • I8OSSP6508 ()


  • Screw endosteal dental implant, two-piece
No Description
Ritter Implants GmbH & Co. KG
i8-OS-SP6506
In Commercial Distribution

  • I8OSSP6506 ()


  • Screw endosteal dental implant, two-piece
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