The following data is part of a premarket notification filed by Osstem Implant Co., Ltd.. with the FDA for Ossbuilder System.
| Device ID | K181854 |
| 510k Number | K181854 |
| Device Name: | OssBuilder System |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | Osstem Implant Co., Ltd.. 66-16, Bansong-ro 513beon-gil, Haeundae-gu Busan, KR 612-070 |
| Contact | Jungmin Yoo |
| Correspondent | Peter Lee Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-11 |
| Decision Date | 2019-05-07 |