Integra External Fixation System— 510(k) K160830

Substantially Equivalent

Ascension Orthopedics

FDA 510(k) clearance K160830 for Integra External Fixation System, Substantially Equivalent on 2016-07-06. Applicant: Ascension Orthopedics.

Clearance details

Applicant: Ascension Orthopedics
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2016-03-25
Decision date: 2016-07-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

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.