Sleds
Medial Malleolar Sled with Welded Washer, 42mm
2manufacturers in China registered for this device type
10catalogue 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) | K010545 |
| Record published | 2016-09-07 |
| Record revised | 2025-07-14 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MMSLED-35 | In distribution | |
| MMSLED-42 | In distribution | |
| OSN-50 | In distribution | |
| OSN-70 | In distribution | |
| OSN-W-70 | In distribution | |
| WMMSLED-42 | In distribution | |
| WMMSLED-35 | In distribution | |
| MMSLED-60 | In distribution | |
| OSN-W-50 | In distribution | |
| MPP-WIRE | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Wireforms | Trimed, Inc. | 21 |
| K-wires | Trimed, Inc. | 21 |
| 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.