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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 a medical device manufactured by Double Medical Technology, Inc.. It received FDA 510(k) clearance on 2016-08-22 under approval 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. It is manufactured by Double Medical Technology, Inc.. The 510(k) number is K151458.

When was Double Medical Universal Spine System approved by the FDA?

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

What company makes Double Medical Universal Spine System?

Double Medical Universal Spine System is manufactured by Double Medical Technology, Inc..

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

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

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Double Medical Technology, Inc.

K172830Double Medical Femoral Nail System K172828Double Medical Cage System K221221Advanced Intramedullary Nail System K220921Metal Bone Screw K233078Posterior Cervical Spine System K223753Cervical Plate System

View all 12 devices →

Related Devices (Code: MNI)

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. K152324YAHUA Spinal SystemBeijing Weigao Yahua Artificial Joint Development 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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