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FDA 510(k)

Double Medical Universal Spine System

K-Number: K151458 · 2016-08-22

ApplicantDouble Medical Technology, Inc.
Decision Date2016-08-22
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Double Medical Universal Spine System is the device name listed in this FDA 510(k) record. The listed applicant is Double Medical Technology, Inc.. It received FDA 510(k) clearance on 2016-08-22 under 510(k) number K151458. 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 Double Medical Universal Spine System?

Double Medical Universal Spine System is a medical device that received FDA 510(k) clearance on 2016-08-22. The listed applicant is Double Medical Technology, Inc.. The 510(k) number is K151458.

When did Double Medical Universal Spine System receive FDA 510(k) clearance?

Double Medical Universal Spine System received FDA 510(k) clearance on 2016-08-22, under 510(k) number K151458.

Who is the listed applicant for Double Medical Universal Spine System?

The FDA 510(k) record lists Double Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Double Medical Universal Spine System?

The FDA product code for Double Medical Universal Spine System is MNI.

Other records listing Double Medical Technology, Inc. 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.

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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.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.K160003Sniper (R) Spine SystemSpine Wave, Inc.

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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