KYPHON VuE Bone Cement— 510(k) K220131

Name: FDA 510(k) clearance K220131
Creator: U.S. Food and Drug Administration
Published: 2022-04-18

Substantially Equivalent

Tecres S.P.A.

FDA 510(k) clearance K220131 for KYPHON VuE Bone Cement, Substantially Equivalent on 2022-04-18. Applicant: Tecres S.P.A.. Device class: 2.

Clearance details

Applicant: Tecres S.P.A.
Product code: Code NDN
Device class: Class 2
Regulation: 21 CFR 888.3027
Advisory panel: Orthopedic
Date received: 2022-01-18
Decision date: 2022-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sommacampagna, IT

Download summary PDF View on FDA.gov ↗

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K181732 — InterSpace Knee Extra-Large Size, InterSpace Knee ATS2019-04-27
K122175 — MENDEC SPINE HV, MENDEC SPINE HV SYSTEM2013-03-28
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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.