Zetaplus Soft
FDA 510(k) K024041 · Zhermack S.P.A.
510(k) numberK024041
Submission
- Device name
- Zetaplus Soft
- Applicant
- Zhermack S.P.A.
Bend, OR, US - Received
- December 6, 2002
- Decision date
- December 18, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K050417 | Elite ImplantELW · Traditional | 07/19/2005SE |
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Questions and answers
When was Zetaplus Soft cleared by the FDA?
Zetaplus Soft (K024041) received a 510(k) decision of Substantially Equivalent on December 18, 2002, 12 days after the submission was received.
What is the product code of K024041?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.