FDA Registration
Active
🇹🇼 Taiwan
PAONAN BIOTECH CO., LTD
Reg #: 3007887127
·
FEI: 3007887127
·
Expires 2026
Products
21
Proprietary Names
14
Establishment Types
1
Classifications
21
Registration Details
- Registration Name
- PAONAN BIOTECH CO., LTD
- Registration Number
- 3007887127
- FEI Number
- 3007887127
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3F, No.50, Lane.258, Rueiguang Rd., Neihu District
- City
- Taipei
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K180226
Owner / Operator
- Firm Name
- Paonan Biotech Co., Ltd.
- Operator Number
- 10055949
- Address
- 3F, No.50, Lane.258, Rueiguang Rd., Neihu District,
- City
- Taipei
- State
- TW-TPE
- Postal Code
- 114062
- Country
- TW
- Correspondent
- North Zhong
US Agent
- Business Name
- Qualtech Consulting LLC
- Contact Name
- Travis Hsu
- Address
- 532 Arboles St
- City
- Monterey Park
- State
- CA
- ZIP
- 91754
- Country
- US
- [email protected]
- Phone
- 626 3455899
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2018-08-13 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2024-02-02 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2019-07-12 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2024-02-02 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2019-07-12 |
| Probe | HXB | Class 1 | Orthopedic | No | 2019-07-12 |
| Pusher, Socket | HXO | Class 1 | Orthopedic | No | 2019-07-12 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2019-01-14 |
| Bender | HXW | Class 1 | Orthopedic | No | 2019-07-12 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2024-02-22 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2019-06-27 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | KTW | Class 2 | Orthopedic | No | 2019-06-27 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2019-06-27 |
| Template | HWT | Class 1 | Orthopedic | No | 2019-07-12 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2019-07-12 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2019-07-12 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2023-10-30 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2017-12-05 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2017-12-05 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2017-12-05 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2019-07-12 |
Proprietary Names
Paonan
Biomech
Taps
Awl
Probe
Rod Pusher
Bender
PK High Tibial Osteotomy Correction System
TEMPLATE
TREND Surgical Instrument System
TREND II Surgical Instrument System
Wrench
Nest-C Interbody System
Length Trial
Establishment Types
Manufacture Medical Device