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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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Fortilink-L IBF System - 00191083006772

Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-L-1440-13-6L
Not in Commercial Distribution


  • 14mm (W), 40mm (L), 13mm (H), 6 degrees Lordosis
65-L-1440-13-6L

  • Polymeric spinal interbody fusion cage

Fortilink-L IBF System - 00191083006765

Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-L-1440-13
Not in Commercial Distribution


  • 14mm (W), 40mm (L), 13mm (H)
65-L-1440-13

  • Polymeric spinal interbody fusion cage

Fortilink-L IBF System - 00191083006758

Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-L-1440-11-6L
Not in Commercial Distribution


  • 14mm (W), 40mm (L), 11mm (H), 6 degrees Lordosis
65-L-1440-11-6L

  • Polymeric spinal interbody fusion cage

Fortilink-L IBF System - 00191083006741

Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-L-1440-11
Not in Commercial Distribution


  • 14mm (W), 40mm (L), 11mm (H)
65-L-1440-11

  • Polymeric spinal interbody fusion cage

Fortilink-TS IBF System - 00191083008899

Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-TS-9-26-6L
In Commercial Distribution


  • 9mm (H), 26mm (L), 6 degrees Lordosis
65-TS-9-26-6L

  • Polymeric spinal interbody fusion cage

Fortilink-TS IBF System - 00191083008875

Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-TS-9-22-6L
In Commercial Distribution


  • 9mm (H), 22mm (L), 6 degrees Lordosis
65-TS-9-22-6L

  • Polymeric spinal interbody fusion cage

Fortilink-TS IBF System - 00191083008851

Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-TS-8-26-6L
In Commercial Distribution


  • 8mm (H), 26mm (L), 6 degrees Lordosis
65-TS-8-26-6L

  • Polymeric spinal interbody fusion cage

Fortilink-TS IBF System - 00191083008837

Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-TS-8-22-6L
In Commercial Distribution


  • 22mm (W), 45mm (L), 9mm (H)
65-TS-8-22-6L

  • Polymeric spinal interbody fusion cage

Fortilink-TS IBF System - 00191083008813

Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-TS-17-32
In Commercial Distribution


  • 17mm (H), 32mm (L)
65-TS-17-32

  • Polymeric spinal interbody fusion cage

Fortilink-TS IBF System - 00191083008639

Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-TS-14-22-6L
In Commercial Distribution


  • 14mm (H), 22mm (L), 6 degrees Lordosis
65-TS-14-22-6L

  • Polymeric spinal interbody fusion cage
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