Double Medical Technology Inc.
Manufacturer and brand owner in Xiamen, Fujian, China. 14 device types, 482 products catalogued, 12 clearances.
Double Medical Technology Inc. is a contract manufacturer holding a current FDA establishment registration. The registration covers Template, Growing Rod System and 12 other device types. 300 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2013.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3010440433 |
| FEI number | 3010440433 |
| DUNS | 529366055 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 大博医疗科技股份有限公司 |
|---|---|
| Unified social credit code | 913502007617290664 |
| Source | NMPA UDI database |
Location
| City | Xiamen |
|---|---|
| Province | Fujian |
| Address | No. 18, Shanbianhong East Road |
| Postal code | 361026 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | Class 2 | Universal Spinal System | 2025 | 11 |
| Appliance, Fixation, Spinal Intervertebral Body | Class 2 | Cervical Plate System, Universal Spinal System | 2023 | 14 |
| Growing Rod System | Class 2 | Universal Spinal System | 2025 | 1 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | Class 2 | Double Medical Cage System | 2018 | 14 |
| Orthopedic Manual Surgical Instrument | Class 1 | Apex Tibial Nailing System Instrumentation, TINA Derotation Instrument Set, KERRISON Rongeur, black ceramic coating, 2 mm*90 degree*180 mm, Patella Fixation Pin (?1.5) 45mm, Extraction Screw for Screws ?3.5, AO Coupling, Tap, ?4/?4.5 and 54 more | 2017 | 53 |
| Orthosis, Spinal Pedicle Fixation | Class 2 | Double Medical Universal Spine System | 2016 | 13 |
| Orthosis, Spondylolisthesis Spinal Fixation | Class 2 | Double Medical Universal Spine System | 2016 | 13 |
| Passer, Wire, Orthopedic | Class 1 | Apex Tibial Nailing System Instrumentation | 2026 | 9 |
| Plate, Fixation, Bone | Class 2 | Locking Screw, CoCrMo, Advanced Bone Plate, Anatomic Bone Plate, Metal Bone Screw, Metal Cannulated Screw, Double Engine Bone Plate and Bone Screw System | 2013 | 22 |
| Posterior Cervical Screw System | Class 2 | Posterior Cervical Spine System | 2023 | 4 |
| Rod, Fixation, Intramedullary And Accessories | Class 2 | Advanced Intramedullary Nail System, Double Engine Intramedullary Nail System, Double Medical Femoral Nail System, Metal Bone Screw, Metal Cannulated Screw | 2014 | 17 |
| Screw, Fixation, Bone | Class 2 | Locking Screw, CoCrMo, Metal Cannulated Screw, Metal Bone Screw, Advanced Bone Plate, Anatomic Bone Plate, Double Medical Femoral Nail System and 2 more | 2013 | 31 |
| Template | Class 1 | Orthopaedic Positioning Plate | 2026 | 21 |
| Thoracolumbosacral Pedicle Screw System | Class 2 | Universal Spinal System | 2025 | 15 |
Own-Brand Listings
Showing 250 of 300 products listed by this company.
Clearances
12 clearances name Double Medical Technology Inc. as applicant. 2 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.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252729 | 2025-11-18 | NKB | Traditional | This company |
| K242348 | 2024-12-04 | HWC | Abbreviated | This company |
| K233078 | 2023-11-22 | NKG | Traditional | This company |
| K223753 | 2023-03-14 | KWQ | Traditional | This company |
| K221150 | 2023-01-25 | HRS | Traditional | This company |
| K221088 | 2023-01-18 | HRS | Traditional | This company |
| K221090 | 2023-01-10 | HWC | Traditional | This company |
| K221221 | 2022-12-21 | HSB | Traditional | This company |
| K220921 | 2022-12-12 | HWC | Traditional | This company |
| K172830 | 2018-08-24 | HSB | Traditional | This company |
| K172828 | 2018-02-01 | MAX | Traditional | This company |
| K151458 | 2016-08-22 | MNI | Traditional | This company |
| K131609 | 2014-05-21 | HSB | Traditional | Xiamen Double Engine Medical Material Co., Ltd. |
| K130108 | 2013-04-19 | HRS | Traditional | Xiamen Double Engine Medical Material Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2004 |
|---|---|
| Employees | 5000 |
| Factory area | 400000 square meters |
| Main products | Orthopedic implants, Dental implants, Minimally invasive surgery devices, Neurosurgery products, Wound repair |
| Certifications | EU MDR, ISO 13485 |
| Export markets | 80+ countries and regions |
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.