The following data is part of a premarket notification filed by Osstem Implant Co., Ltd. with the FDA for Bone Screw, Bone Tack.
| Device ID | K182881 |
| 510k Number | K182881 |
| Device Name: | Bone Screw, Bone Tack |
| 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 | Jungmin Yoo Osstem Implant Co., Ltd. 66-16, Bansong-ro 513beon-gil, Haeundae-gu Busan, KR 612-070 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-15 |
| Decision Date | 2019-08-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800040654599 | K182881 | 000 |
| 08800000987361 | K182881 | 000 |
| 08800000987354 | K182881 | 000 |
| 08800000987347 | K182881 | 000 |
| 08800000987330 | K182881 | 000 |
| 08800000987323 | K182881 | 000 |
| 08800000987316 | K182881 | 000 |
| 08800000987309 | K182881 | 000 |
| 08800000987293 | K182881 | 000 |