NuVasive NuvaLine Mobile App
FDA 510(k) K162647 · Nu Vasive, Incorporated
510(k) numberK162647
Submission
- Device name
- NuVasive NuvaLine Mobile App
- Applicant
- Nu Vasive, Incorporated
San Diego, CA, US - Received
- September 22, 2016
- Decision date
- May 1, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was NuVasive NuvaLine Mobile App cleared by the FDA?
NuVasive NuvaLine Mobile App (K162647) received a 510(k) decision of Substantially Equivalent on May 1, 2017, 221 days after the submission was received.
What is the product code of K162647?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.