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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 a medical device manufactured by Spectrum Spine, Inc.. It received FDA 510(k) clearance on 2024-05-30 under approval 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. It is manufactured by Spectrum Spine, Inc.. The 510(k) number is K240838.

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

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

What company makes Spectrum Spine Cervical Cage System?

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

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

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

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Other Devices by Spectrum Spine, Inc.

K253377Expandable Titanium PLIF/TLIF System K243074Spectrum Spine Lumbar Cage System

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.

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