The following data is part of a premarket notification filed by Osteonic Co., Ltd with the FDA for Optimus Neuro System - Sterile Kit.
Device ID | K190811 |
510k Number | K190811 |
Device Name: | Optimus NEURO System - Sterile Kit |
Classification | Plate, Cranioplasty, Preformed, Alterable |
Applicant | Osteonic Co., Ltd 505-3Ho, 1206Ho, 38, Digital-ro 29-gil, Guro-gu Seoul, KR 08381 |
Contact | Choi Se Young |
Correspondent | Choi Se Young Osteonic Co., Ltd 505-3Ho, 1206Ho, 38, Digital-ro 29-gil, Guro-gu Seoul, KR 08381 |
Product Code | GWO |
Subsequent Product Code | GRX |
Subsequent Product Code | HBW |
CFR Regulation Number | 882.5320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-03-29 |
Decision Date | 2019-11-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08809595972899 | K190811 | 000 |
08809595972882 | K190811 | 000 |
08809595972875 | K190811 | 000 |
08809595972868 | K190811 | 000 |
08809595972851 | K190811 | 000 |
08809595972844 | K190811 | 000 |
08809595972837 | K190811 | 000 |