UNiD Spine Analyzer
FDA 510(k) K212005 · Medicrea International, Inc.
510(k) numberK212005
Submission
- Device name
- UNiD Spine Analyzer
- Applicant
- Medicrea International, Inc.
Rilleux La Pape, FR - Received
- June 28, 2021
- Decision date
- January 12, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was UNiD Spine Analyzer cleared by the FDA?
UNiD Spine Analyzer (K212005) received a 510(k) decision of Substantially Equivalent on January 12, 2022, 198 days after the submission was received.
What is the product code of K212005?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.