The following data is part of a premarket notification filed by Paonan Biotech Co., Ltd. with the FDA for Nest Interbody System.
| Device ID | K180230 |
| 510k Number | K180230 |
| Device Name: | NEST Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Paonan Biotech Co., Ltd. 3F, No. 50, Lane 258, Rueiguang Rd. Neihu District Taipei City, TW 11491 |
| Contact | Tony Lin |
| Correspondent | Tony Lin Paonan Biotech Co., Ltd. 3F, No. 50, Lane 258, Rueiguang Rd. Neihu District Taipei City, TW 11491 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-26 |
| Decision Date | 2019-01-25 |
| Summary: | summary |