Lyoplant Onlay
FDA 510(k) K122791 · Aesculap, Inc.
510(k) numberK122791
Submission
- Device name
- Lyoplant Onlay
- Applicant
- Aesculap, Inc.
Center Valley, PA, US - Received
- September 12, 2012
- Decision date
- June 4, 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 Lyoplant Onlay cleared by the FDA?
Lyoplant Onlay (K122791) received a 510(k) decision of Substantially Equivalent on June 4, 2013, 265 days after the submission was received.
What is the product code of K122791?
The FDA product code is GXQ – Dura Substitute, a Class II (moderate risk) device regulated under 21 CFR 882.5910.