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 Class Implantable

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8mm LG FP HL Implant, HiJAK™ Stand Alone
ATLAS SPINE, INC.
1123-04-0008
In Commercial Distribution

  • M68111230400080 ()

  • Height: 8 Millimeter
1123-04-0008

  • Polymeric spinal interbody fusion cage
8mm SM FP HL Implant, HiJAK™ Stand Alone
ATLAS SPINE, INC.
1123-03-0008
In Commercial Distribution

  • M68111230300080 ()

  • Height: 8 Millimeter
1123-03-0008

  • Polymeric spinal interbody fusion cage
8mm LG FP Lordotic Implant, HiJAK™ Stand Alone
ATLAS SPINE, INC.
1123-02-0008
In Commercial Distribution

  • M68111230200080 ()

  • Height: 8 Millimeter
1123-02-0008

  • Polymeric spinal interbody fusion cage
8mm SM FP Lordotic Implant, HiJAK™ Stand Alone
ATLAS SPINE, INC.
1123-01-0008
In Commercial Distribution

  • M68111230100080 ()

  • Height: 8 Millimeter
1123-01-0008

  • Polymeric spinal interbody fusion cage
Apache Anchored Cervical Trial - 8mm, Small
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GCV10908S0 ()

  • Height: 8 Millimeter
GCV109-08-S

  • Spinal implant trial
Apache Anchored Cervical Trial - 8mm, Large
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GCV10908L0 ()

  • Height: 8 Millimeter
GCV109-08-L

  • Spinal implant trial
Apache Anchored Cervical Rasp - 8mm, Small
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GCV10808S0 ()

  • Height: 8 Millimeter
GCV108-08-S

  • Bone file/rasp, manual, reusable
Apache Anchored Cervical Rasp - 8mm, Large
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GCV10808L0 ()

  • Height: 8 Millimeter
GCV108-08-L

  • Bone file/rasp, manual, reusable
8mm Small, Parallel Apache Anchored Cervical PEEK
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GCV08SP0 ()

  • Height: 8 Millimeter
GCV-08-SP

  • Facet joint prosthesis
8mm Small, Lordotic Apache Anchored Cervical PEEK
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GCV08SL0 ()

  • Height: 8 Millimeter
GCV-08-SL

  • Facet joint prosthesis
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