The following data is part of a premarket notification filed by Baui Biotech Co., Ltd. with the FDA for Facilis™ Spinal System.
Device ID | K161231 |
510k Number | K161231 |
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 | Betty Yen |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-05-02 |
Decision Date | 2017-01-23 |
Summary: | summary |
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 |