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FDA 510(k)

INERTIA PEDICLE SCREW SYSTEM

K-Number: K090984 · 2009-06-30

ApplicantNexxt Spine, LLC
Decision Date2009-06-30
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INERTIA PEDICLE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nexxt Spine, LLC. It received FDA 510(k) clearance on 2009-06-30 under 510(k) number K090984. 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 INERTIA PEDICLE SCREW SYSTEM?

INERTIA PEDICLE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2009-06-30. The listed applicant is Nexxt Spine, LLC. The 510(k) number is K090984.

When did INERTIA PEDICLE SCREW SYSTEM receive FDA 510(k) clearance?

INERTIA PEDICLE SCREW SYSTEM received FDA 510(k) clearance on 2009-06-30, under 510(k) number K090984.

Who is the listed applicant for INERTIA PEDICLE SCREW SYSTEM?

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

What is the FDA product code for INERTIA PEDICLE SCREW SYSTEM?

The FDA product code for INERTIA PEDICLE SCREW SYSTEM is MNI.

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Other records listing Nexxt 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.

K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemK221905INERTIA CONNEXX Modular Pedicle Screw SystemK220291NEXXT SPINE NAVIGATION SystemK202230NEXXT MATRIXX Stand Alone ALIF SystemK202192STRUXXURE®-L and STRUXXURE®-A Plate SystemK200969NEXXT MATRIXX System

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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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