e-Ortho Shoulder Software v1.1
FDA 510(k) K220758 · FH Industrie
510(k) numberK220758
Submission
- Device name
- e-Ortho Shoulder Software v1.1
- Applicant
- FH Industrie
Quimper Finistere, FR - Received
- March 15, 2022
- Decision date
- September 30, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Avara Software
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| K254003 | JARVIS Metaphyseal StemPHX · Special | 01/09/2026SE |
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| K252411 | JARVIS Glenoid Reverse Shoulder ProsthesisPHX · Special | 08/28/2025SE |
| K242253 | JARVIS Glenoid Reverse Shoulder ProsthesisPHX · Traditional | 11/25/2024SE |
| K232226 | ARROW Off-Centred Humeral InsertPHX · Special | 08/29/2023SE |
| K202024 | ARROW Short Stem Humeral SystemPHX · Traditional | 11/30/2021SE |
| K200127 | TELEGRAPH® EVOLUTION Humeral Nailing SystemHSB · Traditional | 10/01/2020SE |
| K201928 | e-Ortho Shoulder SoftwareLLZ · Traditional | 09/30/2020SE |
Questions and answers
When was e-Ortho Shoulder Software v1.1 cleared by the FDA?
e-Ortho Shoulder Software v1.1 (K220758) received a 510(k) decision of Substantially Equivalent on September 30, 2022, 199 days after the submission was received.
What is the product code of K220758?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.