Mesh Titanium Implant System
FDA 510(k) K951687 · Medicon EG
510(k) numberK951687
Submission
- Device name
- Mesh Titanium Implant System
- Applicant
- Medicon EG
Black Diamond, WA, US - Received
- April 5, 1995
- Decision date
- July 27, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Mesh Titanium Implant System cleared by the FDA?
Mesh Titanium Implant System (K951687) received a 510(k) decision of Substantially Equivalent on July 27, 1995, 113 days after the submission was received.
What is the product code of K951687?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.