Thermofx Mesh
FDA 510(k) K003757 · Bionx Implants, Ltd.
510(k) numberK003757
Submission
- Device name
- Thermofx Mesh
- Applicant
- Bionx Implants, Ltd.
Tampere, FI - Received
- December 6, 2000
- Decision date
- February 7, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Thermofx Mesh cleared by the FDA?
Thermofx Mesh (K003757) received a 510(k) decision of Substantially Equivalent on February 7, 2001, 63 days after the submission was received.
What is the product code of K003757?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.