The following data is part of a premarket notification filed by Osteonic Co., Ltd. with the FDA for Optimus Cmf System.
| Device ID | K140037 |
| 510k Number | K140037 |
| Device Name: | OPTIMUS CMF SYSTEM |
| Classification | Plate, Bone |
| Applicant | OSTEONIC CO., LTD. 505 3 Ho Digital-ro 29-gil, Guro-gu Seoul, KP 152-779 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92831 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-07 |
| Decision Date | 2015-01-20 |
| Summary: | summary |