SHANDONG WEIGAO ORTHOPAEDIC DEVICE CO.,LTD

FDA Device Registration & Listing · weihai Shandong, CN · Registration 3006639944

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006639944
FEI Number
3006639944
Entity Name
SHANDONG WEIGAO ORTHOPAEDIC DEVICE CO.,LTD
City/State/Country
weihai Shandong, CN
Establishment Address
No 26 Xiangjiang Road ,Tourist Resorts, weihai Shandong 264203, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
SHANDONG WEIGAO ORTHOPAEDIC DEVICE CO.,LTD (Owner Number: 10024709)
Owner / Operator Contact Address
No 26 Xiangjiang Road ,Tourist Resorts, weihai, CN-SD 264203, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 Intervertebral fusion device with bone graft, lumbar Appliance, fixation, spinal intervertebral body TRAY, SURGICAL, INSTRUMENT Accessories, arthroscopic Accessories, arthroscopic Orthopedic manual surgical instrument INSTRUMENT, BENDING OR CONTOURING TAMP WRENCH ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Dissector, Surgical, General & Plastic Surgery Intervertebral fusion device with bone graft, lumbar Guide, surgical, instrument Intervertebral fusion device with bone graft, lumbar APPLIANCE, FIXATION, SPINAL INTERLAMINAL SCREWDRIVER

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWN Instrument, Compression Orthopedic Class 1 888.4540 2012-12-13
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-12-13
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-12-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-12-13
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-12-13
NQP Posterior Metal/Polymer Spinal System, Fusion Orthopedic Class 2 888.3070 2012-12-13
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-12-13
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-19
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-19
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-19
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-19
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-19
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2025-01-19
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-19
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-12-13
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-11-07
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-11-07
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2012-12-13
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-02-27
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-02-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-02-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-01-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-01-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-12-13
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-01-19
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-03-22
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2025-01-20
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-20
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2025-01-20
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2025-01-20
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-20
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2025-01-20
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2025-01-20
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2012-12-13
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2012-12-13
FSZ Light, Surgical, Carrier General, Plastic Surgery Class 2 878.4580 2012-12-13
GAD Retractor General, Plastic Surgery Class 1 878.4800 2012-12-13
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2012-12-13
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-20
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2008-02-19
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2025-01-20
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2025-01-20
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2025-01-20
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2025-01-20
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-20
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-20
FST Light, Surgical, Fiberoptic General, Plastic Surgery Class 2 878.4580 2025-01-20
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2025-01-19
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2012-12-13
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-19
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-19
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2025-01-19
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-19
HXG Tamp Orthopedic Class 1 888.4540 2012-12-13
HXC Wrench Orthopedic Class 1 888.4540 2015-11-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-01-20
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-19
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2025-01-19
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-19
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-19
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-19
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2012-12-13
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2023-11-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-10-26
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-19
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-19
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-19
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-19
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-19
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-19
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2025-01-19
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-01-19
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-01-19
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-19
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-19
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-19
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-19
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-19
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-19
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-19
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-19
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-19
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-19
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2025-01-19
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-19
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2025-01-19
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-19
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-19
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2025-01-19
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-19
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-19
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-19
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2012-12-13
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-12-13
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-05-10
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-05-10
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-05-10
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-01-19
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-20
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-01-20
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2025-01-20
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-01-20
HXX Screwdriver Orthopedic Class 1 888.4540 2012-12-13

Official Correspondent

Linda He

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

SHANDONG WEIGAO ORTHOPAEDIC DEVICE CO.,LTD
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K963639 Acromed Corp. ACROMED PEDICLE SCREW 1996-11-14
K012175 Encore Orthopedics, Inc. PASS SPINAL SYSTEM 2001-07-31
K032752 R&B Surgical Solutions, LLC R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM 2003-12-03
K062643 Life Spine KINETIC ANTERIOR CERVICAL PLATE 2006-11-16
K163363 Surgtech, Inc. SurgTech Thoracolumbosacral (TLS) Posterior Fixation System 2017-04-05

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0026-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011 Zimmer Inc. 2
SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006639944. Last updated year: 2026. Please use registration number 3006639944 when referencing this establishment in official correspondence.
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