Dyonics Plan Hip Impingement Planning System
FDA 510(k) K132636 · Smith & Nephew, Inc.
510(k) numberK132636
Submission
- Device name
- Dyonics Plan Hip Impingement Planning System
- Applicant
- Smith & Nephew, Inc.
Andover, MA, US - Received
- August 22, 2013
- Decision date
- October 17, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Dyonics Plan Hip Impingement Planning System cleared by the FDA?
Dyonics Plan Hip Impingement Planning System (K132636) received a 510(k) decision of Substantially Equivalent on October 17, 2013, 56 days after the submission was received.
What is the product code of K132636?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.