Attune Revision LPS Inserts— 510(k) K191779

Substantially Equivalent

Depuy(Ireland)

FDA 510(k) clearance K191779 for Attune Revision LPS Inserts, Substantially Equivalent on 2019-10-08. Applicant: Depuy(Ireland).

Clearance details

Applicant: Depuy(Ireland)
Product code: Code KRO
Advisory panel: Orthopedic
Date received: 2019-07-02
Decision date: 2019-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cork, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code KRO

product code KRO

Death: 19
Injury: 4,841
Total: 4,860

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.