The following data is part of a premarket notification filed by Medicrea International, Inc. with the FDA for Unid Spine Analyzer.
| Device ID | K212005 |
| 510k Number | K212005 |
| Device Name: | UNiD Spine Analyzer |
| Classification | System, Image Processing, Radiological |
| Applicant | MEDICREA International, Inc. 5389 Route De Strasbourg - Vancia Rilleux La Pape, FR 69140 |
| Contact | David Ryan |
| Correspondent | Teal Bjoraker Sterling Medical Devices 250 Moonachie Road Moonachie, NJ 07074 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-28 |
| Decision Date | 2022-01-12 |