AutoStrut— 510(k) K191241

Substantially Equivalent

Orthospin

FDA 510(k) clearance K191241 for AutoStrut, Substantially Equivalent on 2019-08-14. Applicant: Orthospin.

Clearance details

Applicant: Orthospin
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2019-05-08
Decision date: 2019-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Misgav, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.