The following data is part of a premarket notification filed by Neobiotech Co., Ltd. with the FDA for Neo Gbr System.
| Device ID | K160991 |
| 510k Number | K160991 |
| Device Name: | Neo GBR System |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | NEOBIOTECH CO., LTD. #312-2,36, Digital-ro 27 Gil, Guro-gu Seoul, KR 08381 |
| Contact | In Ho Kim |
| Correspondent | April Lee WITHUS GROUP INC 2531 PEPPERDALE DRIVE Rowland Heights, CA 91748 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-08 |
| Decision Date | 2017-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809276765307 | K160991 | 000 |
| 08809276765291 | K160991 | 000 |
| 08809276765284 | K160991 | 000 |
| 08809276765277 | K160991 | 000 |
| 08809276765260 | K160991 | 000 |
| 08809276765253 | K160991 | 000 |
| 08809276765246 | K160991 | 000 |
| 08809276765154 | K160991 | 000 |