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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-A IBF System - 00846468093983

Interbody Fusion Device
Pioneer Surgical Technology, Inc.
65-A-M20-20L
In Commercial Distribution

  • 00846468093983 ()

  • 36mm (W)27mm (D)20mm (H)20 (L)
65-A-M20-20L

  • Polymeric spinal interbody fusion cage

Unison®-C Anterior Cervical Fixation System - 00846468080853

Interbody Fusion Device, 22mm (W), 16mm (D), 12mm (H), 7° Lordosis
Pioneer Surgical Technology, Inc.
64-2216-12-7L
Not in Commercial Distribution

  • 00846468080853 ()

  • 22mm (W), 16mm (D), 12mm (H), 7° Lordosis
64-2216-12-7L

  • Polymeric spinal interbody fusion cage

Unison™-C Anterior Cervical Fixation System - 00846468075590

Stand-Alone Cervical Interbody Fusion Device
Pioneer Surgical Technology, Inc.
63-2016-12-7L
Not in Commercial Distribution

  • 00846468075590 ()
63-2016-12-7L

  • Polymeric spinal interbody fusion cage

Unison™-C Anterior Cervical Fixation System - 00846468075583

Stand-Alone Cervical Interbody Fusion Device
Pioneer Surgical Technology, Inc.
63-2016-11-7L
Not in Commercial Distribution

  • 00846468075583 ()
63-2016-11-7L

  • Polymeric spinal interbody fusion cage

Unison™-C Anterior Cervical Fixation System - 00846468075569

Stand-Alone Cervical Interbody Fusion Device
Pioneer Surgical Technology, Inc.
63-2016-9-7L
Not in Commercial Distribution

  • 00846468075569 ()
63-2016-9-7L

  • Polymeric spinal interbody fusion cage

Unison™-C Anterior Cervical Fixation System - 00846468075545

Stand-Alone Cervical Interbody Fusion Device
Pioneer Surgical Technology, Inc.
63-2016-7-7L
Not in Commercial Distribution

  • 00846468075545 ()
63-2016-7-7L

  • Polymeric spinal interbody fusion cage

Unison™-C Anterior Cervical Fixation System - 00846468075521

Stand-Alone Cervical Interbody Fusion Device
Pioneer Surgical Technology, Inc.
63-2014-12-7L
Not in Commercial Distribution

  • 00846468075521 ()
63-2014-12-7L

  • Polymeric spinal interbody fusion cage

Unison™-C Anterior Cervical Fixation System - 00846468075514

Stand-Alone Cervical Interbody Fusion Device
Pioneer Surgical Technology, Inc.
63-2014-11-7L
Not in Commercial Distribution

  • 00846468075514 ()


  • Polymeric spinal interbody fusion cage

Unison™-C Anterior Cervical Fixation System - 00846468075507

Stand-Alone Cervical Interbody Fusion Device
Pioneer Surgical Technology, Inc.
63-2014-10-7L
Not in Commercial Distribution

  • 00846468075507 ()
63-2014-10-7L

  • Polymeric spinal interbody fusion cage

Unison™-C Anterior Cervical Fixation System - 00846468073695

Stand-Alone Cervical Interbody Fusion Device
Pioneer Surgical Technology, Inc.
63-1412-6-7L
Not in Commercial Distribution

  • 00846468073695 ()
63-1412-6-7L

  • Polymeric spinal interbody fusion cage
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