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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-TS IBF System - 00191083008431

Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-TS-10-22-6L
In Commercial Distribution


  • 10mm (H), 22mm (L), 6 degrees Lordosis
65-TS-10-22-6L

  • Polymeric spinal interbody fusion cage

Fortilink-TS IBF System - 00191083008424

Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-TS-10-22
In Commercial Distribution


  • 10mm (H), 22mm (L)
65-TS-10-22

  • Polymeric spinal interbody fusion cage

Fortilink-L IBF System - 00191083008417

Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-L-2660-9-6L
Not in Commercial Distribution


  • 26mm (W), 60mm (L), 9mm (H), 6 degrees Lordosis
65-L-2660-9-6L

  • Polymeric spinal interbody fusion cage

Fortilink-L IBF System - 00191083008400

Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-L-2660-15-6L
Not in Commercial Distribution


  • 26mm (W), 60mm (L), 15mm (H), 6 degrees Lordosis
65-L-2660-15-6L

  • Polymeric spinal interbody fusion cage

Fortilink-L IBF System - 00191083008394

Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-L-2660-15-12L
Not in Commercial Distribution


  • 26mm (W), 60mm (L), 15mm (H), 12 degrees Lordosis
65-L-2660-15-12L

  • Polymeric spinal interbody fusion cage

Fortilink-L IBF System - 00191083008387

Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-L-2660-13-6L
Not in Commercial Distribution


  • 26mm (W), 60mm (L), 13mm (H), 6 degrees Lordosis
65-L-2660-13-6L

  • Polymeric spinal interbody fusion cage

Fortilink-L IBF System - 00191083008370

Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-L-2660-13-12L
Not in Commercial Distribution


  • 26mm (W), 60mm (L), 13mm (H), 12 degrees Lordosis
65-L-2660-13-12L

  • Polymeric spinal interbody fusion cage

Fortilink-L IBF System - 00191083008363

Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-L-2660-11-6L
Not in Commercial Distribution


  • 26mm (W), 60mm (L), 11mm (H), 6 degrees Lordosis
65-L-2660-11-6L

  • Polymeric spinal interbody fusion cage

Fortilink-L IBF System - 00191083008356

Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-L-2655-9-6L
Not in Commercial Distribution


  • 26mm (W), 55mm (L), 9mm (H), 6 degrees Lordosis
65-L-2655-9-6L

  • Polymeric spinal interbody fusion cage

Fortilink-L IBF System - 00191083008349

Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-L-2655-15-6L
Not in Commercial Distribution


  • 26mm (W), 55mm (L), 15mm (H), 6 degrees Lordosis
65-L-2655-15-6L

  • Polymeric spinal interbody fusion cage
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