MEDINAUT Kyphoplasty System— 510(k) K153296

Name: FDA 510(k) clearance K153296
Creator: U.S. Food and Drug Administration
Published: 2016-07-29

Substantially Equivalent

Imedicom Co., Ltd.

FDA 510(k) clearance K153296 for MEDINAUT Kyphoplasty System, Substantially Equivalent on 2016-07-29. Applicant: Imedicom Co., Ltd.. Device class: 2.

Clearance details

Applicant: Imedicom Co., Ltd.
Product code: Code NDN
Device class: Class 2
Regulation: 21 CFR 888.3027
Advisory panel: Orthopedic
Date received: 2015-11-13
Decision date: 2016-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gunpo-Si, KR

Download summary PDF View on FDA.gov ↗

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K182287 — MEDINAUT Plus2019-04-06
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K150915 — SPINAUT-P2016-03-18
K151268 — SPINAUT-V, SPINAUT-S, SPINAUT-I2016-03-16
K150789 — SPINAUT-E, SPINAUT-I2016-03-01

Adverse events under product code NDN

product code NDN

Death: 24
Injury: 407
Malfunction: 1,975
Total: 2,406

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.