FDA Registration
Active
🇨🇳 China
ZIBO DANTE CO, LTD
Reg #: 3012711663
·
FEI: 3012711663
·
Expires 2026
Products
17
Proprietary Names
38
Establishment Types
1
Classifications
17
Registration Details
- Registration Name
- ZIBO DANTE CO, LTD
- Registration Number
- 3012711663
- FEI Number
- 3012711663
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 206 Industry Yi Road, Huantai
- City
- Zibo City Shandong
- Country
- CN
Owner / Operator
- Firm Name
- Zibo Dante Co, LTD
- Operator Number
- 10058316
- Address
- No. 206 Industry Yi Road, Huantai
- City
- Zibo City
- State
- Shandong
- Postal Code
- 256400
- Country
- CN
- Correspondent
- Angela Batker
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-02-07 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2025-02-07 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2019-01-15 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2019-01-15 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2025-02-14 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2025-02-14 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2025-02-06 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2025-02-06 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2023-05-03 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2025-02-14 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2021-04-19 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2019-04-05 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2018-08-24 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2019-01-15 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2025-02-07 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2019-01-17 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2025-08-21 |
Proprietary Names
Simpact
ARX
Kinetic
Sentry
Plateau-C
Nautilus/Avatar
ProLift Wedge
Forefoot Screw
Neo
ProLift Lateral Fixated
ProLift Lateral Instruments
Pro Lift
Plateau Instruments
Solstice Instruments
Lynx
ProLift Micro
Plateau
Kinetic-SL
Gruve
Suction Tube
Aileron
Manual Surgical Instruments
Plateau-C Instruments
External Fixation
ARx
Arx Illiac
Dyna-Link Ti
Solstice
Centerline Modular
Pro-Link
Ultrasonic Dental Tip
Solstice OCT Instruments
Neo SL
Pro Link
TruLift
Nautilus Instruments
Pro Link Instruments
ProLift Instruments
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)