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FDA 510(k)

INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE

K-Number: K093808 · 2010-03-24

ApplicantIncite Innovation, LLC
Decision Date2010-03-24
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INCITE INNOVATION STAND ALONE INTERBODY 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 2010-03-24 under 510(k) number K093808. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE?

INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE is a medical device that received FDA 510(k) clearance on 2010-03-24. The listed applicant is Incite Innovation, LLC. The 510(k) number is K093808.

When did INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE receive FDA 510(k) clearance?

INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE received FDA 510(k) clearance on 2010-03-24, under 510(k) number K093808.

Who is the listed applicant for INCITE INNOVATION STAND ALONE INTERBODY 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 INNOVATION STAND ALONE INTERBODY FUSION DEVICE?

The FDA product code for INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE is OVD.

Related Clinical Trials

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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 DEVICEK122008INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE

Related Devices (Code: OVD)

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.

K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF SystemINNO Holdings Inc. DBA InnovasisK261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.

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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