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510(k) K253377

Expandable Titanium PLIF/TLIF System by Spectrum Spine, Inc. — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2025
Date Received
September 30, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Spectrum Spine, Inc.

  • K243074 — Spectrum Spine Lumbar Cage System (April 4, 2025)
  • K240838 — Spectrum Spine Cervical Cage System (May 30, 2024)
  • K201024 — Expandable Titanium PLIF/TLIF System (April 29, 2021)
  • K173518 — Spectrum Spine Expandable Cages (SSEC) (March 7, 2019)
  • K132126 — SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM (October 28, 2013)
  • K122822 — SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM (February 7, 2013)

Other clearances for product code MAX

  • K254017 — SWINGO-3D Lumbar Cage System (February 26, 2026)
  • K253583 — LUX Expandable Lumbar Interbody System (February 23, 2026)
  • K250773 — Luna® Ti Interbody Fusion System (February 4, 2026)
  • K253748 — Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spac (January 23, 2026)
  • K253266 — Titanium Interbody System (January 8, 2026)
  • K253577 — IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) (December 19, 2025)
  • K252610 — ZSFab Lumbar Interbody System (November 25, 2025)
  • K252351 — UniSpace® TPLIF Cage (October 28, 2025)
  • K251479 — Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion C (September 18, 2025)
  • K251444 — Endoskeleton™ Interbody Systems (September 4, 2025)