KYPHON VuE Bone Cement— 510(k) K220131

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..

Clearance details

Applicant: Tecres S.P.A.
Product code: Code NDN
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 ↗

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.