Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters— 510(k) K172214

Substantially Equivalent

G-21 S.R.L.

FDA 510(k) clearance K172214 for Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters, Substantially Equivalent on 2017-08-23. Applicant: G-21 S.R.L..

Clearance details

Applicant: G-21 S.R.L.
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2017-07-24
Decision date: 2017-08-23
Decision: Substantially Equivalent
Clearance type: Special
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.