ApolloHipX (THR.SS.0001)
FDA 510(k) K241808 · Corin U.S.A. Limited
510(k) numberK241808
Submission
- Device name
- ApolloHipX (THR.SS.0001)
- Applicant
- Corin U.S.A. Limited
Tampa, FL, US - Received
- June 21, 2024
- Decision date
- January 7, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was ApolloHipX (THR.SS.0001) cleared by the FDA?
ApolloHipX (THR.SS.0001) (K241808) received a 510(k) decision of Substantially Equivalent on January 7, 2025, 200 days after the submission was received.
What is the product code of K241808?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.