FDA 510(k)

Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System

K-Number: K252240 · 2026-03-30

Decision Date2026-03-30

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Spine. It received FDA 510(k) clearance on 2026-03-30 under 510(k) number K252240. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System?

Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System is a medical device that received FDA 510(k) clearance on 2026-03-30. The listed applicant is Spectrum Spine. The 510(k) number is K252240.

When did Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System receive FDA 510(k) clearance?

Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System received FDA 510(k) clearance on 2026-03-30, under 510(k) number K252240.

Who is the listed applicant for Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System?

The FDA 510(k) record lists Spectrum Spine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System?

The FDA product code for Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System is ODP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITING NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION NCT06720948The ION Facet Screw System Ambispective EvaluationENROLLING_BY_INVITATION NCT06971835INDUCE: A Prospective 2-Year Spine RegistryENROLLING_BY_INVITATION NCT07739979Radiological Outcome of Bony Fusion After Single Level Anterior Cervical Discectomy and Fusion Using Iliac Crest Graft vs. Polyetheretherketone Cage in Cervical SpondylosisCOMPLETED

Other records listing Spectrum Spine as applicant

K253377Expandable Titanium PLIF/TLIF System K243074Spectrum Spine Lumbar Cage System K240838Spectrum Spine Cervical Cage System K201024Expandable Titanium PLIF/TLIF System K173518Spectrum Spine Expandable Cages (SSEC)

Related Devices (Code: ODP)

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker Spine K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.