The following data is part of a premarket notification filed by Osteonic Co., Ltd. with the FDA for Optimus Cmf System.
| Device ID | K160363 |
| 510k Number | K160363 |
| Device Name: | OPTIMUS CMF SYSTEM |
| Classification | Plate, Bone |
| Applicant | OSTEONIC Co., Ltd. 1206ho, 38, Digital-ro 29-gil, Guro-gu Seoul, KR |
| Contact | Jisun Lee |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt Ste 417 Irvine, CA 92620 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-09 |
| Decision Date | 2016-10-20 |
| Summary: | summary |