Optimus Neuro System
FDA 510(k) K141911 · Osteonic Co., Ltd.
510(k) numberK141911
Submission
- Device name
- Optimus Neuro System
- Applicant
- Osteonic Co., Ltd.
Fullerton, CA, US - Received
- July 15, 2014
- Decision date
- February 10, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K230546 | SignexHRS · Traditional | 06/11/2024SE |
| K233659 | Suture WingMBI · Special | 12/26/2023SE |
| K231322 | Fix2Lock(PEEK Self Punching)MBI · Special | 06/07/2023SE |
| K231326 | Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)MAI · Special | 05/31/2023SE |
| K210360 | Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro…GWO · Traditional | 01/27/2022SE |
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Questions and answers
When was Optimus Neuro System cleared by the FDA?
Optimus Neuro System (K141911) received a 510(k) decision of Substantially Equivalent on February 10, 2015, 210 days after the submission was received.
What is the product code of K141911?
The FDA product code is GWO – Plate, Cranioplasty, Preformed, Alterable, a Class II (moderate risk) device regulated under 21 CFR 882.5320.