Double Medical Technology Inc.
Xiamen Fujian, CN
Double Medical Technology Inc. appears in FDA device records in Xiamen Fujian, CN. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Double Medical Technology Inc. between 2016 and 2025. The busiest year on record is 2023, with 5. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2018 | 2 |
| 2022 | 2 |
| 2023 | 5 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252729 | Universal Spinal System | NKB | Substantially Equivalent | |
| K242348 | Locking Screw,CoCrMo | HWC | Substantially Equivalent | |
| K233078 | Posterior Cervical Spine System | NKG | Substantially Equivalent | |
| K223753 | Cervical Plate System | KWQ | Substantially Equivalent | |
| K221150 | Advanced Bone Plate | HRS | Substantially Equivalent | |
| K221088 | Anatomic Bone Plate | HRS | Substantially Equivalent | |
| K221090 | Metal Cannulated Screw | HWC | Substantially Equivalent | |
| K221221 | Advanced Intramedullary Nail System | HSB | Substantially Equivalent | |
| K220921 | Metal Bone Screw | HWC | Substantially Equivalent | |
| K172830 | Double Medical Femoral Nail System | HSB | Substantially Equivalent | |
| K172828 | Double Medical Cage System | MAX | Substantially Equivalent | |
| K151458 | Double Medical Universal Spine System | MNI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010440433 | 3010440433 | Double Medical Technology Inc. | No. 18, Shanbianhong East Road, Xiamen Fujian 361026 CN | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- PGMGrowing Rod System
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- LXHOrthopedic Manual Surgical Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HXIPasser, Wire, Orthopedic
- HRSPlate, Fixation, Bone
- NKGPosterior Cervical Screw System
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- HWTTemplate
- NKBThoracolumbosacral Pedicle Screw System
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Double Medical Technology Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain