The following data is part of a premarket notification filed by Baui Biotech Co., Ltd. with the FDA for Comet Lumbar Interbody Fusion Cage.
| Device ID | K191353 |
| 510k Number | K191353 |
| Device Name: | COMET Lumbar Interbody Fusion Cage |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | BAUI Biotech Co., Ltd. 6F.,No.8, Sec.1, Zongxing Rd., Wugu Dist., New Taipei City, TW 24872 |
| Contact | Jessy Lin |
| Correspondent | Jessy Lin BAUI Biotech Co., Ltd. 6F., No.8, Sec.1, Zongxing Rd., Wugu Dist., New Taipei City, TW 24872 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-21 |
| Decision Date | 2020-04-14 |