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FDA 510(k)

INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE

K-Number: K122008 · 2012-11-16

ApplicantIncite Innovation, LLC
Decision Date2012-11-16
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Incite Innovation, LLC. It received FDA 510(k) clearance on 2012-11-16 under 510(k) number K122008. 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 INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE?

INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE is a medical device that received FDA 510(k) clearance on 2012-11-16. The listed applicant is Incite Innovation, LLC. The 510(k) number is K122008.

When did INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE receive FDA 510(k) clearance?

INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE received FDA 510(k) clearance on 2012-11-16, under 510(k) number K122008.

Who is the listed applicant for INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE?

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

What is the FDA product code for INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE?

The FDA product code for INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE is OVE.

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Other records listing Incite Innovation, 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.

K130306INCITE ANCHORED CERVICAL INTERBODY DEVICEK093808INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE

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.

K263049SABER-C SystemElevation SpineK261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLCK261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, 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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