INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL— 510(k) K132620

Substantially Equivalent

Pan Medical , Ltd.

FDA 510(k) clearance K132620 for INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL, Substantially Equivalent on 2014-04-16. Applicant: Pan Medical , Ltd..

Clearance details

Applicant: Pan Medical , Ltd.
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2013-08-21
Decision date: 2014-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gloucester, Gloucestershire, GB

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.