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FDA 510(k)

FIXPINE II SYSTEM

K-Number: K100765 · 2010-07-19

ApplicantDio Medical Co., Ltd.
Decision Date2010-07-19
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIXPINE II SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dio Medical Co., Ltd.. It received FDA 510(k) clearance on 2010-07-19 under 510(k) number K100765. 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 FIXPINE II SYSTEM?

FIXPINE II SYSTEM is a medical device that received FDA 510(k) clearance on 2010-07-19. The listed applicant is Dio Medical Co., Ltd.. The 510(k) number is K100765.

When did FIXPINE II SYSTEM receive FDA 510(k) clearance?

FIXPINE II SYSTEM received FDA 510(k) clearance on 2010-07-19, under 510(k) number K100765.

Who is the listed applicant for FIXPINE II SYSTEM?

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

What is the FDA product code for FIXPINE II SYSTEM?

The FDA product code for FIXPINE II SYSTEM is MNI.

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Other records listing Dio Medical Co., Ltd. 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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