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FDA 510(k)

INERTIA PEDICLE SCREW SYSTEM

K-Number: K101278 · 2010-12-20

ApplicantNexxt Spine, LLC
Decision Date2010-12-20
Product CodeMNH
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 2010-12-20 under 510(k) number K101278. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. 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 2010-12-20. The listed applicant is Nexxt Spine, LLC. The 510(k) number is K101278.

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

INERTIA PEDICLE SCREW SYSTEM received FDA 510(k) clearance on 2010-12-20, under 510(k) number K101278.

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 MNH. This falls under the ENT category.

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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: MNH)

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.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S 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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