Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System

K-Number: K252240 · 2026-03-30

ApplicantSpectrum Spine
Decision Date2026-03-30
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System is a medical device manufactured by Spectrum Spine. It received FDA 510(k) clearance on 2026-03-30 under approval 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. It is manufactured by Spectrum Spine. The 510(k) number is K252240.

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

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

What company makes Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System?

Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System is manufactured by Spectrum Spine.

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

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07610850 Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation NOT_YET_RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_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)

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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.

↑