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FDA 510(k)

Cervical Stand-Alone System

K-Number: K212853 · 2021-11-05

ApplicantEminent Spine, LLC
Decision Date2021-11-05
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cervical Stand-Alone System is the device name listed in this FDA 510(k) record. The listed applicant is Eminent Spine, LLC. It received FDA 510(k) clearance on 2021-11-05 under 510(k) number K212853. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cervical Stand-Alone System?

Cervical Stand-Alone System is a medical device that received FDA 510(k) clearance on 2021-11-05. The listed applicant is Eminent Spine, LLC. The 510(k) number is K212853.

When did Cervical Stand-Alone System receive FDA 510(k) clearance?

Cervical Stand-Alone System received FDA 510(k) clearance on 2021-11-05, under 510(k) number K212853.

Who is the listed applicant for Cervical Stand-Alone System?

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

What is the FDA product code for Cervical Stand-Alone System?

The FDA product code for Cervical Stand-Alone System is OVE.

Related Clinical Trials

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Other records listing Eminent Spine, LLC 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.

K250894Eminent Spine Posterior SI SystemK241663Eminent Spine 3D Titanium Pedicle Screw SystemK242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemK240505Eminent Spine SI Screw SystemK230219Eminent Spine 3D Lumbar Interbody Fusion SystemsK212701Eminent Spine 3D Cervical Interbody Fusion System

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Related Devices (Code: OVE)

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.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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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