The following data is part of a premarket notification filed by Fh Industrie with the FDA for E-ortho Shoulder Software V1.1.
| Device ID | K220758 |
| 510k Number | K220758 |
| Device Name: | E-Ortho Shoulder Software V1.1 |
| Classification | System, Image Processing, Radiological |
| Applicant | FH Industrie ZI De Kernevez - 6 Rue Nobel Quimper, FR 29000 |
| Contact | Oscar Ramirez |
| Correspondent | Dawn N. Norman MRC Global, LLC 9085 E. Mineral Circle, Suite 110 Centennial, CO 80112 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-15 |
| Decision Date | 2022-09-30 |