ATEC Alignment App
FDA 510(k) K211987 · Alphatec Spine, Inc.
510(k) numberK211987
Submission
- Device name
- ATEC Alignment App
- Applicant
- Alphatec Spine, Inc.
Carlsbad, CA, US - Received
- June 28, 2021
- Decision date
- October 29, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was ATEC Alignment App cleared by the FDA?
ATEC Alignment App (K211987) received a 510(k) decision of Substantially Equivalent on October 29, 2021, 123 days after the submission was received.
What is the product code of K211987?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.