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FDA 510(k)

Spectrum Spine Lumbar Cage System

K-Number: K243074 · 2025-04-04

ApplicantSpectrum Spine, Inc.
Decision Date2025-04-04
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Spectrum Spine Lumbar Cage System is a medical device manufactured by Spectrum Spine, Inc.. It received FDA 510(k) clearance on 2025-04-04 under approval number K243074. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spectrum Spine Lumbar Cage System?

Spectrum Spine Lumbar Cage System is a medical device that received FDA 510(k) clearance on 2025-04-04. It is manufactured by Spectrum Spine, Inc.. The 510(k) number is K243074.

When was Spectrum Spine Lumbar Cage System approved by the FDA?

Spectrum Spine Lumbar Cage System received FDA 510(k) clearance on 2025-04-04, under approval number K243074.

What company makes Spectrum Spine Lumbar Cage System?

Spectrum Spine Lumbar Cage System is manufactured by Spectrum Spine, Inc..

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

The FDA product code for Spectrum Spine Lumbar Cage System is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07277803 Device-Based vs Manual Sensory Training in Low Back Pain NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026)

Other Devices by Spectrum Spine, Inc.

K240838Spectrum Spine Cervical Cage System K253377Expandable Titanium PLIF/TLIF System

Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.

Official Source

View on FDA Database →

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

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