Data / Medical devices / Taiwan / Baui Biotech Co., Ltd.
Baui Biotech Co., Ltd.: FDA-registered device maker in New Taipei City, Taiwan, 5 510(k) clearances
Baui Biotech Co., Ltd. is registered with the FDA (registration 3013514648) in New Taipei City, Taiwan. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 17, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013514648
- Address
- 6F., No.8, Sec.1, Zhongxing Rd. Wugu Dist., New Taipei City, Taiwan, 24872
- Owner or operator
- BAUI BIOTECH CO., LTD. (10054111)
- Roles
- Manufacturer
- First device listed
- February 13, 2017
- Registered through
- 2026
- Brand names listed
- BAUI Orthopedic manual surgical instrument, COMET Lumbar Interbody Fusion Cage, Facilis Spinal System, NOVA Minimally Invasive System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 17, 2024 | K242899 | NOVA Minimally Invasive System | NKB | Substantially Equivalent | Baui Biotech Co., Ltd. | accessdata.fda.gov |
| April 14, 2020 | K191353 | COMET Lumbar Interbody Fusion Cage | MAX | Substantially Equivalent | Baui Biotech Co., Ltd. | accessdata.fda.gov |
| August 12, 2019 | K191494 | Facilis Spinal System | NKB | Substantially Equivalent | Baui Biotech Co., Ltd. | accessdata.fda.gov |
| June 11, 2019 | K182416 | NOVA Minimally Invasive System | NKB | Substantially Equivalent | Baui Biotech Co., Ltd. | accessdata.fda.gov |
| January 23, 2017 | K161231 | Facilis Spinal System | NKB | Substantially Equivalent | Baui Biotech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Appliance, Fixation, Spinal Interlaminal
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
Updated October 17, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.