Facilis™ Spinal System
Thoracolumbosacral Pedicle Screw System
Baui Biotech Co., Ltd.
The following data is part of a premarket notification filed by Baui Biotech Co., Ltd. with the FDA for Facilis™ Spinal System.
Pre-market Notification Details
| Device ID | K191494 |
| 510k Number | K191494 |
| Device Name: | Facilis™ Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Baui Biotech Co., Ltd. 6F., No. 8, Sec.1, Zhongxing Rd., Wugu Dist. New Taipei City, TW 24872 |
| Contact | Herman Jhan |
| Correspondent | Herman Jhan Baui Biotech Co., Ltd. 6F., No. 8, Sec.1, Zhongxing Rd., Wugu Dist. New Taipei City, TW 24872 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-05 |
| Decision Date | 2019-08-12 |
Trademark Results [Facilis]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FACILIS 85393222 4125464 Live/Registered |
Facilis Technology Inc. 2011-08-09 |
 FACILIS 74236271 1726300 Dead/Cancelled |
Dallas Medical Resource 1992-01-09 |
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