K-Wires
K-Wire 1.1, 150mm Double Trocar
2manufacturers in China registered for this device type
21catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Autocam Medical Devices (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
Record
| Listed by | Trimed, Inc., United States |
|---|---|
| FDA product code | NDL |
| Device type | Pin, Fixation, Smooth, Metallic |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K243943 |
| Record published | 2025-04-23 |
| Record revised | 2024-08-15 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2019-07-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| WIRE-0.7/100 | In distribution | |
| WIRE-1.1/150D | In distribution | |
| WIRE-1.6/100 | In distribution | |
| WIRE-1.1/150 | In distribution | |
| WIRE-0.7/100D | In distribution | |
| WIRE-2.0/060 | In distribution | |
| WIRE-2.0/230 | In distribution | |
| WIRE-2.5/230 | In distribution | |
| WIRE-0.8/120 | In distribution | |
| WIRE-0.8/120D | In distribution | |
| WIRE-0.8/080 | In distribution | |
| WIRE-1.6/150 | In distribution | |
| WIRE-0.7/080 | In distribution | |
| WIRE-1.6/230 | In distribution | |
| WIRE-0.9/100 | In distribution | |
| WIRE-1.6/130 | In distribution | |
| WIRE-1.1/120D | In distribution | |
| WIRE-1.1/120 | In distribution | |
| WIRE-1.6/065 | In distribution | |
| WIRE-1.1/100 | In distribution | |
| OLIVE-1.6/100 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Wireforms | Trimed, Inc. | 21 |
| Sleds | Trimed, Inc. | 10 |
| Generic Instruments | Trimed, Inc. | 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.