FDA Registration
Active
🇨🇳 China
SHANDONG WEIGAO ORTHOPAEDIC DEVICE CO.,LTD
Reg #: 3006639944
·
FEI: 3006639944
·
Expires 2026
Products
42
Proprietary Names
22
Establishment Types
2
Classifications
42
Registration Details
- Registration Name
- SHANDONG WEIGAO ORTHOPAEDIC DEVICE CO.,LTD
- Registration Number
- 3006639944
- FEI Number
- 3006639944
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No 26 Xiangjiang Road ,Tourist Resorts
- City
- weihai Shandong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K170861
Owner / Operator
- Firm Name
- SHANDONG WEIGAO ORTHOPAEDIC DEVICE CO.,LTD
- Operator Number
- 10024709
- Address
- No 26 Xiangjiang Road ,Tourist Resorts
- City
- weihai
- State
- Shandong
- Postal Code
- 264203
- Country
- CN
- Correspondent
- Linda He
US Agent
- Business Name
- MID-LINK INTERNATIONAL CO., LTD
- Contact Name
- Marco Mu
- Address
- 2219 Rimlang Drive, Suite 301
- City
- Bellingham
- State
- WA
- ZIP
- 98226
- Country
- US
- [email protected]
- Phone
- 702 2095185
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2012-12-13 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2012-12-13 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2012-12-13 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2012-12-13 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2012-12-13 |
| Posterior Metal/Polymer Spinal System, Fusion | NQP | Class 2 | Orthopedic | No | 2012-12-13 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2012-12-13 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2025-01-19 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-01-19 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2012-12-13 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2018-01-16 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2018-01-16 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2025-01-19 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2025-01-20 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2025-01-20 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2025-01-20 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2025-01-20 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2025-01-20 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2025-01-20 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2025-01-20 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2012-12-13 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2012-12-13 |
| Light, Surgical, Carrier | FSZ | Class 2 | General, Plastic Surgery | No | 2012-12-13 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2012-12-13 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2008-02-19 |
| Light, Surgical, Fiberoptic | FST | Class 2 | General, Plastic Surgery | No | 2025-01-20 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2025-01-19 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2012-12-13 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2025-01-19 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2012-12-13 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2015-11-23 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2025-01-20 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2012-12-13 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2023-11-16 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2025-01-19 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2025-01-19 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2012-12-13 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2025-01-20 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2012-12-13 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2021-08-24 |
| Probe | HXB | Class 1 | Orthopedic | No | 2012-12-13 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2012-12-13 |
Proprietary Names
INSTRUMENT, COMPRESSION
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Intervertebral fusion device with bone graft, lumbar
Thoracolumbosacral pedicle screw system
Spinal vertebral body replacement device
General Spinal System
Plate, Screw, fixation, bone
Appliance, fixation, spinal intervertebral body
TRAY, SURGICAL, INSTRUMENT
Accessories, arthroscopic
Orthopedic manual surgical instrument
INSTRUMENT, BENDING OR CONTOURING
TAMP
WRENCH
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Dissector, Surgical, General & Plastic Surgery
Guide, surgical, instrument
SCREWDRIVER
TRANSITION STABILIZATION SYSTEM
BROACH
PROBE
AWL
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)