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
Phone
702 2095185

Products

Device Name Product Code
Instrument, Compression HWN
Appliance, Fixation, Spinal Interlaminal KWP
Orthosis, Spinal Pedicle Fixation MNI
Appliance, Fixation, Spinal Intervertebral Body KWQ
Thoracolumbosacral Pedicle Screw System NKB
Posterior Metal/Polymer Spinal System, Fusion NQP
Orthosis, Spondylolisthesis Spinal Fixation MNH
Intervertebral Fusion Device With Bone Graft, Thoracic PHM
Intervertebral Fusion Device With Bone Graft, Lumbar MAX
Spinal Vertebral Body Replacement Device MQP
Plate, Fixation, Bone HRS
Screw, Fixation, Bone HWC
Intervertebral Fusion Device With Bone Graft, Cervical ODP
Stimulator, Electrical, Evoked Response GWF
Orthopedic Stereotaxic Instrument OLO
Stimulator, Nerve ETN
Neurosurgical Nerve Locator PDQ
Neurological Stereotaxic Instrument HAW
Electromyograph, Diagnostic IKN
Bone Fixation Cerclage, Sublaminar OWI
Tray, Surgical, Instrument FSM
Accessories, Arthroscopic NBH
Light, Surgical, Carrier FSZ
Retractor GAD
Orthopedic Manual Surgical Instrument LXH
Light, Surgical, Fiberoptic FST
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
Instrument, Bending Or Contouring HXP
Bone Cement, Posterior Screw Augmentation PML
Tamp HXG
Wrench HXC
Electrosurgical, Cutting & Coagulation & Accessories GEI
Rod, Fixation, Intramedullary And Accessories HSB
Dissector, Surgical, General & Plastic Surgery GDI
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
Spinal Vertebral Body Replacement Device - Cervical PLR
Guide, Surgical, Instrument FZX
Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
Screwdriver HXX
Broach HTQ
Probe HXB
Awl HWJ

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)