SKELTEX ISV— 510(k) K091234

Substantially Equivalent

Skeltex Technologies, Inc.

FDA 510(k) clearance K091234 for SKELTEX ISV, Substantially Equivalent on 2010-02-16. Applicant: Skeltex Technologies, Inc..

Clearance details

Applicant: Skeltex Technologies, Inc.
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2009-04-27
Decision date: 2010-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boucherville, Quebec, CA

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.