Micro Titanium Plate System
FDA 510(k) K951688 · Medicon EG
510(k) numberK951688
Submission
- Device name
- Micro Titanium Plate System
- Applicant
- Medicon EG
Black Diamond, WA, US - Received
- April 5, 1995
- Decision date
- July 26, 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 Micro Titanium Plate System cleared by the FDA?
Micro Titanium Plate System (K951688) received a 510(k) decision of Substantially Equivalent on July 26, 1995, 112 days after the submission was received.
What is the product code of K951688?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.