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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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Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-L-1855-15
Not in Commercial Distribution


  • 18mm (W), 55mm (L), 15mm (H)
65-L-1855-15

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-L-1855-13-6L
Not in Commercial Distribution


  • 18mm (W), 55mm (L), 13mm (H), 6 degrees Lordosis
65-L-1855-13-6L

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-L-1855-13-12L
Not in Commercial Distribution


  • 18mm (W), 55mm (L), 13mm (H), 12 degrees Lordosis
65-L-1855-13-12L

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-L-1855-13
Not in Commercial Distribution


  • 18mm (W), 55mm (L), 13mm (H)
65-L-1855-13

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-L-1855-11-6L
Not in Commercial Distribution


  • 18mm (W), 55mm (L), 11mm (H), 6 degrees Lordosis
65-L-1855-11-6L

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-L-1855-11-12L
Not in Commercial Distribution


  • 18mm (W), 55mm (L), 11mm (H), 12 degrees Lordosis
65-L-1855-11-12L

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-L-1855-11
Not in Commercial Distribution


  • 18mm (W), 55mm (L), 11mm (H)
65-L-1855-11

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-L-1850-9-6L
Not in Commercial Distribution


  • 18mm (W), 50mm (L), 9mm (H), 6 degrees Lordosis
65-L-1850-9-6L

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-L-1850-9
Not in Commercial Distribution


  • 18mm (W), 50mm (L), 15mm (H), 6 degrees Lordosis
65-L-1850-9

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-L-1850-8
Not in Commercial Distribution


  • 18mm (W), 50mm (L), 8mm (H)
65-L-1850-8

  • Polymeric spinal interbody fusion cage
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