The following data is part of a premarket notification filed by Neobiotech Co., Ltd. with the FDA for Neo Titanium Mesh, Cti-mem.
| Device ID | K111761 |
| 510k Number | K111761 |
| Device Name: | NEO TITANIUM MESH, CTI-MEM |
| Classification | Plate, Bone |
| Applicant | NEOBIOTECH CO., LTD. 1733 CANTON LANE Marietta, GA 30006 |
| Contact | Ron Arkin |
| Correspondent | Ron Arkin NEOBIOTECH CO., LTD. 1733 CANTON LANE Marietta, GA 30006 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-23 |
| Decision Date | 2012-01-10 |
| Summary: | summary |