Data / Medical devices / Pin, Fixation, Smooth, Metallic
Pin, Fixation, Smooth, Metallic (NDL): 8 FDA-registered makers in 3 countries
8 establishments in 3 countries are registered with the FDA to make Pin, Fixation, Smooth, Metallic (product code NDL, Class 2, 21 CFR 888.3040). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on June 19, 2001, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NDL
- Device class
- 2
- Regulation
- 888.3040
- Medical specialty
- Orthopedic
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| China | 2 |
| Taiwan | 1 |
Makers of Pin, Fixation, Smooth, Metallic
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Trimed, Inc. | Santa Clarita, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 1 | June 6, 2001 | 0 | 0 | 0 | api.fda.gov |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical Devices (Suzhou) Co. Ltd. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CB Enterprises | Canyon Country, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maxkron Machine, LLC | Valencia, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miing Wei Co., Ltd. | Tsao-Twon Nantou, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical, Inc. | Pierceton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quadm Technologies, LLC | Hamilton, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 19, 2001. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.