Kontour (Xi’an) Medical Technology Co., Ltd.
Manufacturer and brand owner in Xi'An, Shaanxi, China. 4 device types, 2 products catalogued, 1 clearance.
Kontour (Xi’an) Medical Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Plate, Bone, Cover, Burr Hole and 2 other device types. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
4device types registered with the FDA
2products catalogued under its own name
1510(k) clearance
Registration
| Registered name | KONTOUR (XI’AN) MEDICAL TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011423165 |
| FEI number | 3011423165 |
| DUNS | 529652129 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Xi’An |
|---|---|
| Province | Shaanxi |
| Address | No.1451, 1st Biyuan Road, High-tech District, |
| Postal code | 710065 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Cover, Burr Hole | Class 2 | Titanuim Fixation System | 2020 | 3 |
| Plate, Bone | Class 2 | Biomesh, Modification to Bioplate Rigid Fixation System, Modified Screw Design, Modified Sterile Plate and Screw Configuration, Bioplate Rigid Fixation System, Sterile Plate and Screw Configuration | 2020 | 3 |
| Plate, Cranioplasty, Preformed, Non-Alterable | Class 2 | PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) | 2022 | 3 |
| Screwdriver, Skullplate | Class 1 | Disposable Screwdriver Blade | 2024 | 2 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) | GXN | 162 |
| Disposable Screwdriver Blade | GXL | 2 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K214109 | 2022-10-28 | GXN | Traditional | This company |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Xian Friendship Medical Electronics Co., Ltd. | 10 |
| Xian Tianlong Science AND Technology Co., Ltd. | 8 |
| Xi’an Furuize Biotechnology Co., Ltd. | 8 |
| Shaanxi Ansen Medical Technology Development Co., Ltd. | 7 |
| Xi’an Haiye Medical Equipment Co,.ltd. | 3 |
| Xi’an Henghui Technology, Ltd | 1 |
| Xi’an Centeringone International Trading & Consultants Ltd. | 1 |
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.