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510(k) K253377

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

K253377 is an FDA 510(k) premarket notification submitted by Spectrum Spine, Inc. for the device "Expandable Titanium PLIF/TLIF System". The FDA issued a decision of Substantially Equivalent on October 24, 2025. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Spectrum Spine, Inc. has at least 7 other 510(k) clearances on record.

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.

  • K252240 — Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (March 30, 2026)
  • 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

  • K253011 — Catalyft PL Expandable Interbody System (July 17, 2026)
  • K261020 — Symmetrix™ L Spinal System (July 14, 2026)
  • K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Space (July 1, 2026)
  • K253151 — Fule Interbody Fusion Cage System (June 15, 2026)
  • K261159 — Exceed® Biplanar Expandable Interbody System (May 29, 2026)
  • K253894 — BMD Titanium Spinal Fusion System (May 28, 2026)
  • K260506 — Ventana® P/T Lumbar Interbody System (May 15, 2026)
  • K260837 — VersaLift Expandable System (May 12, 2026)
  • K260385 — aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and tran (May 9, 2026)
  • K261067 — BEE PLIF Cage (April 30, 2026)

FDA data resources