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FDA 510(k)

NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM

K-Number: K110284 · 2011-06-08

ApplicantMedyssey Co, Ltd.
Decision Date2011-06-08
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medyssey Co, Ltd.. It received FDA 510(k) clearance on 2011-06-08 under 510(k) number K110284. 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 NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM?

NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-06-08. The listed applicant is Medyssey Co, Ltd.. The 510(k) number is K110284.

When did NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM receive FDA 510(k) clearance?

NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM received FDA 510(k) clearance on 2011-06-08, under 510(k) number K110284.

Who is the listed applicant for NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM?

The FDA 510(k) record lists Medyssey Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM?

The FDA product code for NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM is MNI.

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Other records listing Medyssey Co, Ltd. 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.

K260036NeckTune™ 3D SA Cervical CageK242806Medyssey Navigation SystemK121670MEDYSSEY CANNULATED PEDICLE SCREWK121320C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGEK121246MEDYSSY LT CAGE SYSTEMK110283ZENIUS SPINAL 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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