The following data is part of a premarket notification filed by Osteonic Co., Ltd. with the FDA for Sterile Bone Screw (peek Acl Screw).
| Device ID | K202883 |
| 510k Number | K202883 |
| Device Name: | Sterile Bone Screw (PEEK ACL Screw) |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Osteonic Co., Ltd. 38 Digital-ro 29-gil Guro-gu, KR 08381 |
| Contact | Sungmoo Hwang |
| Correspondent | Sanglok Lee Wise Company Inc. #507-508, 166 Gasan Digital 2-ro Geumcheon-gu, KR 08503 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-28 |
| Decision Date | 2020-11-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800071019077 | K202883 | 000 |
| 08800071019060 | K202883 | 000 |
| 08800071019053 | K202883 | 000 |
| 08800071019046 | K202883 | 000 |
| 08800071019039 | K202883 | 000 |
| 08800071019022 | K202883 | 000 |
| 08800071019015 | K202883 | 000 |
| 08800071019008 | K202883 | 000 |