Shandong Weigao Orthopaedic Device Co., Ltd.

Manufacturer and brand owner in Weihai, Shandong, China. 42 device types, 50 products catalogued, 2 clearances.

Registry build 21.09.26

Shandong Weigao Orthopaedic Device Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Awl, Tamp and 40 other device types. 50 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2008.

42device types registered with the FDA
50products catalogued under its own name
2510(k) clearances

Registration

FDA registration record for Shandong Weigao Orthopaedic Device Co., Ltd.
Registered name SHANDONG WEIGAO ORTHOPAEDIC DEVICE CO.,LTD
Status Registered
Registration expires 2026
Registration number 3006639944
FEI number 3006639944
DUNS 545249039
Establishment type Contract manufacturer, Manufacturer

Chinese Registration

Chinese company register details for Shandong Weigao Orthopaedic Device Co., Ltd.
Chinese legal name 山东威高骨科材料股份有限公司
Unified social credit code 91370000773168024E
Source NMPA UDI database

Location

Address of Shandong Weigao Orthopaedic Device Co., Ltd.
City Weihai
Province Shandong
Address No 26 Xiangjiang Road ,Tourist Resorts
Postal code 264203
Country China

What It Makes

Device types Shandong Weigao Orthopaedic Device Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Accessories, Arthroscopic Class 1 Accessories, arthroscopic 2012 14
Appliance, Fixation, Spinal Interlaminal Class 2 General Spinal System, Appliance, Fixation, Spinal Interlaminal, Thoracolumbosacral pedicle screw system 2012 11
Appliance, Fixation, Spinal Intervertebral Body Class 2 Appliance, Fixation, Spinal Interlaminal, Appliance, fixation, spinal intervertebral body 2012 14
Awl Class 1 AWL 2012 13
Bone Cement, Posterior Screw Augmentation Class 2 2025 2
Bone Fixation Cerclage, Sublaminar Class 2 2025 1
Broach Class 1 Broach 2021 12
Dissector, Surgical, General & Plastic Surgery Class 1 Dissector, Surgical, General & Plastic Surgery 2023 14
Electromyograph, Diagnostic Class 2 Transition Stabilization System 2025 2
Electrosurgical, Cutting & Coagulation & Accessories Class 2 2025 65
Guide, Surgical, Instrument Class 1 Guide, surgical, instrument 2012 26
Instrument, Bending Or Contouring Class 1 Instrument, Bending OR Contouring 2012 5
Instrument, Compression Class 1 Instrument, Compression 2012 8
Intervertebral Fusion Device With Bone Graft, Cervical Class 2 2025 7
Intervertebral Fusion Device With Bone Graft, Lumbar Class 2 Intervertebral fusion device with bone graft, lumbar 2012 14
Intervertebral Fusion Device With Bone Graft, Thoracic Class 2 2025 1
Intervertebral Fusion Device With Integrated Fixation, Lumbar Class 2 2025 3
Light, Surgical, Carrier Class 2 Accessories, arthroscopic 2012 2
Light, Surgical, Fiberoptic Class 2 2025 1
Neurological Stereotaxic Instrument Class 2 Transition Stabilization System 2025 5
Neurosurgical Nerve Locator Class 2 Transition Stabilization System 2025 1
Orthopedic Manual Surgical Instrument Class 1 Orthopedic manual surgical instrument 2008 53
Orthopedic Stereotaxic Instrument Class 2 Transition Stabilization System 2025 5
Orthosis, Spinal Pedicle Fixation Class 2 General Spinal System, Appliance, Fixation, Spinal Interlaminal 2012 13
Orthosis, Spondylolisthesis Spinal Fixation Class 2 General Spinal System, Appliance, Fixation, Spinal Interlaminal 2012 13
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Class 2 2025 7
Plate, Fixation, Bone Class 2 Plate, Screw, fixation, bone 2018 22
Posterior Metal/Polymer Spinal System, Fusion Class 2 Appliance, Fixation, Spinal Interlaminal 2012 4
Probe Class 1 Probe 2012 12
Retractor Class 1 Accessories, arthroscopic 2012 34
Rod, Fixation, Intramedullary And Accessories Class 2 ROD, Fixation, Intramedullary AND Accessories 2012 17
Screw, Fixation, Bone Class 2 Plate, Screw, fixation, bone 2018 31
Screwdriver Class 1 Screwdriver 2012 18
Spinal Vertebral Body Replacement Device Class 2 Spinal vertebral body replacement device 2012 3
Spinal Vertebral Body Replacement Device – Cervical Class 2 2025 1
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories Class 2 2025 5
Stimulator, Electrical, Evoked Response Class 2 Transition Stabilization System 2025 3
Stimulator, Nerve Class 2 Transition Stabilization System 2025 8
Tamp Class 1 Tamp 2012 7
Thoracolumbosacral Pedicle Screw System Class 2 Appliance, Fixation, Spinal Interlaminal, Thoracolumbosacral pedicle screw system 2012 15
Tray, Surgical, Instrument Class 1 Tray, Surgical, Instrument 2012 105
Wrench Class 1 Wrench 2015 14

Own-Brand Listings

Clearances

2 clearances name Shandong Weigao Orthopaedic Device Co., Ltd. as applicant. 5 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming Shandong Weigao Orthopaedic Device Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K170861 2017-08-04 NKB Traditional This company
K160320 2016-04-01 MNI Traditional This company
K133053 2014-07-15 MAX Traditional Weigao Orthopaedic Device Co., Ltd.
K122994 2013-04-12 MNH Traditional Weigao Orthopaedic Device Co., Ltd.
K130340 2013-04-05 HRS Traditional Weigao Orthopaedic Device Co., Ltd.
K123578 2013-02-01 KWQ Traditional Weigao Orthopaedic Device Co., Ltd.
K121312 2012-10-24 HSB Traditional Weigao Orthopaedic Device Co., Ltd.

From the Company

Published by the company on its own website, not by the FDA.

Information published by Shandong Weigao Orthopaedic Device Co., Ltd.
Founded 2004
Main products Spine implants, Joint devices, Trauma implants, Sports medicine devices, Orthopedic instruments
Export markets 100+ countries

Nearby Manufacturers

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer