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FDA 510(k)

CERTEX SPINAL IMPLANT SYSTEM

K-Number: K122163 · 2012-10-31

ApplicantX-Spine Systems, Inc.
Decision Date2012-10-31
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CERTEX SPINAL IMPLANT 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 2012-10-31 under 510(k) number K122163. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERTEX SPINAL IMPLANT SYSTEM?

CERTEX SPINAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2012-10-31. The listed applicant is X-Spine Systems, Inc.. The 510(k) number is K122163.

When did CERTEX SPINAL IMPLANT SYSTEM receive FDA 510(k) clearance?

CERTEX SPINAL IMPLANT SYSTEM received FDA 510(k) clearance on 2012-10-31, under 510(k) number K122163.

Who is the listed applicant for CERTEX SPINAL IMPLANT 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 CERTEX SPINAL IMPLANT SYSTEM?

The FDA product code for CERTEX SPINAL IMPLANT SYSTEM is MNI.

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

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Related Devices (Code: MNI)

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.

K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co. , Ltd.K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.

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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