Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters— 510(k) K152557

Substantially Equivalent

G21, S.R.L.

FDA 510(k) clearance K152557 for Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters, Substantially Equivalent on 2016-02-23. Applicant: G21, S.R.L..

Clearance details

Applicant: G21, S.R.L.
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2015-09-08
Decision date: 2016-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Possidonio, 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.