ApolloHipX (THR.SS.0001)— 510(k) K241808

Substantially Equivalent

Corin U.S.A. Limited

FDA 510(k) clearance K241808 for ApolloHipX (THR.SS.0001), Substantially Equivalent on 2025-01-07. Applicant: Corin U.S.A. Limited.

Clearance details

Applicant: Corin U.S.A. Limited
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2024-06-21
Decision date: 2025-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.