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: 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