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FDA 510(k)

IRIX-A Lumbar Integrated Fusion System

K-Number: K171567 · 2017-08-28

ApplicantX-Spine Systems, Inc.
Decision Date2017-08-28
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IRIX-A Lumbar Integrated Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2017-08-28 under 510(k) number K171567. 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 IRIX-A Lumbar Integrated Fusion System?

IRIX-A Lumbar Integrated Fusion System is a medical device that received FDA 510(k) clearance on 2017-08-28. The listed applicant is X-Spine Systems, Inc.. The 510(k) number is K171567.

When did IRIX-A Lumbar Integrated Fusion System receive FDA 510(k) clearance?

IRIX-A Lumbar Integrated Fusion System received FDA 510(k) clearance on 2017-08-28, under 510(k) number K171567.

Who is the listed applicant for IRIX-A Lumbar Integrated Fusion System?

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

What is the FDA product code for IRIX-A Lumbar Integrated Fusion System?

The FDA product code for IRIX-A Lumbar Integrated Fusion System is OVD.

Other records listing X-Spine Systems, Inc. as applicant

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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.

K261408SABER-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.K253401SCRIPT™ Implant SystemGlobus Medical, 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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