Imtec/Titanium Mesh
FDA 510(k) K970841 · Imtec Corp.
510(k) numberK970841
Submission
- Device name
- Imtec/Titanium Mesh
- Applicant
- Imtec Corp.
Ardmore, OK, US - Received
- March 7, 1997
- Decision date
- April 30, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Imtec/Titanium Mesh cleared by the FDA?
Imtec/Titanium Mesh (K970841) received a 510(k) decision of Substantially Equivalent on April 30, 1997, 54 days after the submission was received.
What is the product code of K970841?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.