Cleared Traditional

ApolloHipX (THR.SS.0001)

K241808 · Corin U.S.A. Limited · Radiology
Jan 2025
Decision
200d
Days
Class 2
Risk

About This 510(k) Submission

K241808 is an FDA 510(k) clearance for the ApolloHipX (THR.SS.0001), a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Corin U.S.A. Limited (Tampa, US). The FDA issued a Cleared decision on January 7, 2025, 200 days after receiving the submission on June 21, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K241808 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2024
Decision Date January 07, 2025
Days to Decision 200 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050