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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Interbody Fusion Device 6 Degree Large 12mm
TITAN SPINE, LLC
5186-1612-S
Not in Commercial Distribution

  • M68251861612S0 ()

  • Lordotic Angle 6 Deg
  • Height: 12 Millimeter
  • Angle: 6 degree
  • Depth: 16 Millimeter
  • width(MLxAP), 18 x 16, mm
  • Width: 18 Millimeter
5186-1612-S

  • Metallic spinal interbody fusion cage
Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Large 12mm
TITAN SPINE, LLC
5186-1612-N
Not in Commercial Distribution

  • M68251861612N0 ()

  • Lordotic Angle 6 Deg
  • Height: 12 Millimeter
  • Width: 18 Millimeter
  • width(MLxAP), 18 x 16, mm
  • Angle: 6 degree
  • Depth: 16 Millimeter
5186-1612-N

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 6 Degree Large 12mm
TITAN SPINE, LLC
5186-1612
Not in Commercial Distribution

  • M682518616120 ()

  • Height: 12 Millimeter
  • Lordotic Angle 6 Deg
  • Depth: 16 Millimeter
  • Width: 18 Millimeter
  • Angle: 6 degree
  • width(MLxAP), 18 x 16, mm
5186-1612

  • Metallic spinal interbody fusion cage
Interbody Fusion Device Parallel Large 12mm
TITAN SPINE, LLC
5180-1612-S
Not in Commercial Distribution

  • M68251801612S0 ()

  • Height: 12 Millimeter
  • Parallel
  • width(MLxAP), 18 x 16, mm
  • Depth: 16 Millimeter
  • Width: 18 Millimeter
5180-1612-S

  • Metallic spinal interbody fusion cage
Interbody Fusion Device nanoLOCK Surface Technology Parallel Large 12mm
TITAN SPINE, LLC
5180-1612-N
Not in Commercial Distribution

  • M68251801612N0 ()

  • Parallel
  • Height: 12 Millimeter
  • Width: 18 Millimeter
  • Depth: 16 Millimeter
  • width(MLxAP), 18 x 16, mm
5180-1612-N

  • Metallic spinal interbody fusion cage
Interbody Fusion Device Parallel Large 12mm
TITAN SPINE, LLC
5180-1612
Not in Commercial Distribution

  • M682518016120 ()

  • Height: 12 Millimeter
  • Parallel
  • width(MLxAP), 18 x 16, mm
  • Depth: 16 Millimeter
  • Width: 18 Millimeter
5180-1612

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 6 Degree Medium 12mm
TITAN SPINE, LLC
5166-1412-S
Not in Commercial Distribution

  • M68251661412S0 ()

  • Lordotic Angle 6 Deg
  • Height: 12 Millimeter
  • width(MLxAP), 16 x 14, mm
  • Angle: 6 degree
  • Width: 16 Millimeter
  • Depth: 14 Millimeter
5166-1412-S

  • Metallic spinal interbody fusion cage
Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Medium 12mm
TITAN SPINE, LLC
5166-1412-N
Not in Commercial Distribution

  • M68251661412N0 ()

  • Lordotic Angle 6 Deg
  • Height: 12 Millimeter
  • Width: 16 Millimeter
  • Depth: 14 Millimeter
  • width(MLxAP), 16 x 14, mm
  • Angle: 6 degree
5166-1412-N

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 6 Degree Medium 12mm
TITAN SPINE, LLC
5166-1412
Not in Commercial Distribution

  • M682516614120 ()

  • Lordotic Angle 6 Deg
  • Height: 12 Millimeter
  • Depth: 14 Millimeter
  • Width: 16 Millimeter
  • Angle: 6 degree
  • width(MLxAP), 16 x 14, mm
5166-1412

  • Metallic spinal interbody fusion cage
Interbody Fusion Device Parallel Small 12mm
TITAN SPINE, LLC
5140-1212-S
Not in Commercial Distribution

  • M68251401212S0 ()

  • Parallel
  • Height: 12 Millimeter
  • width(MLxAP), 14 x 12, mm
  • Width: 14 Millimeter
  • Depth: 12 Millimeter
5140-1212-S

  • Metallic spinal interbody fusion cage
Interbody Fusion Device nanoLOCK Surface Technology Parallel Small 12mm
TITAN SPINE, LLC
5140-1212-N
Not in Commercial Distribution

  • M68251401212N0 ()

  • Height: 12 Millimeter
  • Parallel
  • Depth: 12 Millimeter
  • Width: 14 Millimeter
  • width(MLxAP), 14 x 12, mm
5140-1212-N

  • Metallic spinal interbody fusion cage
Interbody Fusion Device Parallel Small 12mm
TITAN SPINE, LLC
5140-1212
Not in Commercial Distribution

  • M682514012120 ()

  • Height: 12 Millimeter
  • Parallel
  • Width: 14 Millimeter
  • Depth: 12 Millimeter
  • width(MLxAP), 14 x 12, mm
5140-1212

  • Metallic spinal interbody fusion cage
12mm LG Lordotic Expanding Trial, HiJAK™ Cervical
ATLAS SPINE, INC.
2019-09-0012
In Commercial Distribution

  • M68120190900120 ()

  • Height: 12 Millimeter
2019-09-0012

  • Spinal implant trial
12mm LG HL Expanding Trial, HiJAK™ Cervical
ATLAS SPINE, INC.
2019-07-0012
In Commercial Distribution

  • M68120190700120 ()

  • Height: 12 Millimeter
2019-07-0012

  • Spinal implant trial
12mm SM HL Expanding Trial, HiJAK™ Cervical
ATLAS SPINE, INC.
2019-06-0012
In Commercial Distribution

  • M68120190600120 ()

  • Height: 12 Millimeter
2019-06-0012

  • Spinal implant trial
12mm LG Lordotic Static Trial, HiJAK™ Cervical
ATLAS SPINE, INC.
2019-05-0012
In Commercial Distribution

  • M68120190500120 ()

  • Height: 12 Millimeter
2019-05-0012

  • Spinal implant trial
12mm SM Lordotic Static Trial, HiJAK™ Cervical
ATLAS SPINE, INC.
2019-04-0012
In Commercial Distribution

  • M68120190400120 ()

  • Height: 12 Millimeter
2019-04-0012

  • Spinal implant trial
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.
ISRO1620L12CB1
In Commercial Distribution

  • ISRO1620L12CB1 ()

  • Width: 20 Millimeter
  • Depth: 16 Millimeter
  • Angle: 6 degree
  • Height: 12 Millimeter
ISRO1620L12CB1

  • 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.
ISRO1620L12CA1
In Commercial Distribution

  • ISRO1620L12CA1 ()

  • Depth: 16 Millimeter
  • Angle: 6 degree
  • Width: 20 Millimeter
  • Height: 12 Millimeter
ISRO1620L12CA1

  • 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.
ISRO1620A12CB1
In Commercial Distribution

  • ISRO1620A12CB1 ()

  • Angle: 6 degree
  • Height: 12 Millimeter
  • Width: 20 Millimeter
  • Depth: 16 Millimeter
ISRO1620A12CB1

  • Polymeric spinal interbody fusion cage
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