Double Medical Universal Spine System— 510(k) K151458

Name: FDA 510(k) clearance K151458
Creator: U.S. Food and Drug Administration
Published: 2016-08-22

Substantially Equivalent

Double Medical Technology, Inc.

FDA 510(k) clearance K151458 for Double Medical Universal Spine System, Substantially Equivalent on 2016-08-22. Applicant: Double Medical Technology, Inc.. Device class: 2.

Clearance details

Applicant: Double Medical Technology, Inc.
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2015-06-01
Decision date: 2016-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xiamen, CN

Download summary PDF View on FDA.gov ↗

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More clearances from Double Medical Technology, Inc.

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K252729 — Universal Spinal System2025-11-18
K242348 — Locking Screw,CoCrMo2024-12-04
K233078 — Posterior Cervical Spine System2023-11-22
K223753 — Cervical Plate System2023-03-14
K221150 — Advanced Bone Plate2023-01-25

Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.