Joline Kyphoplasty System Allevo— 510(k) K192449

Substantially Equivalent

Joline GmbH & Co. KG

FDA 510(k) clearance K192449 for Joline Kyphoplasty System Allevo, Substantially Equivalent on 2020-05-27. Applicant: Joline GmbH & Co. KG.

Clearance details

Applicant: Joline GmbH & Co. KG
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2019-09-06
Decision date: 2020-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hechingen, DE

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.