INTEGRA EXTERNAL FIXATION SYSTEM— 510(k) K140463

Substantially Equivalent

Ascension Orthopedic

FDA 510(k) clearance K140463 for INTEGRA EXTERNAL FIXATION SYSTEM, Substantially Equivalent on 2014-10-10. Applicant: Ascension Orthopedic.

Clearance details

Applicant: Ascension Orthopedic
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2014-02-24
Decision date: 2014-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Providence, UT, 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.