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FDA 510(k)

Spectrum Spine Cervical Cage System

K-Number: K240838 · 2024-05-30

ApplicantSpectrum Spine, Inc.
Decision Date2024-05-30
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Spectrum Spine Cervical Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Spine, Inc.. It received FDA 510(k) clearance on 2024-05-30 under 510(k) number K240838. 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 Cervical Cage System is a medical device that received FDA 510(k) clearance on 2024-05-30. The listed applicant is Spectrum Spine, Inc.. The 510(k) number is K240838.

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

Spectrum Spine Cervical Cage System received FDA 510(k) clearance on 2024-05-30, under 510(k) number K240838.

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

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

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

The FDA product code for Spectrum Spine Cervical 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_RECRUITINGNCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATIONNCT07739979Radiological 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, Inc. as applicant

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.

K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemK253377Expandable Titanium PLIF/TLIF SystemK243074Spectrum Spine Lumbar Cage SystemK201024Expandable Titanium PLIF/TLIF SystemK173518Spectrum Spine Expandable Cages (SSEC)

Related Devices (Code: ODP)

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.

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 SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX 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.

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