AutoStrut G2— 510(k) K202810

Substantially Equivalent

Orthospin, Ltd.

FDA 510(k) clearance K202810 for AutoStrut G2, Substantially Equivalent on 2021-01-06. Applicant: Orthospin, Ltd..

Clearance details

Applicant: Orthospin, Ltd.
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2020-09-23
Decision date: 2021-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam, 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.