Optimus CMF System
FDA 510(k) K140037 · Osteonic Co., Ltd.
510(k) numberK140037
Submission
- Device name
- Optimus CMF System
- Applicant
- Osteonic Co., Ltd.
Seoul, KR - Received
- January 7, 2014
- Decision date
- January 20, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Optimus CMF System cleared by the FDA?
Optimus CMF System (K140037) received a 510(k) decision of Substantially Equivalent on January 20, 2015, 378 days after the submission was received.
What is the product code of K140037?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.