V-STRUT® Vertebral Implant— 510(k) K240084

Substantially Equivalent

Hyprevention

FDA 510(k) clearance K240084 for V-STRUT® Vertebral Implant, Substantially Equivalent on 2024-02-09. Applicant: Hyprevention.

Clearance details

Applicant: Hyprevention
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2024-01-11
Decision date: 2024-02-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Pessac, FR

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.