Data / Medical devices / South Korea / Primemed Inc.
Primemed Inc.: FDA-registered device maker in Sungnam-city Gyeonggi, South Korea, 1 510(k) clearance
Primemed Inc. is registered with the FDA (registration 3017609305) in Sungnam-city Gyeonggi, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 19, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017609305
- Address
- 107 Intium, 1244 Sungnamdaero, Sujung-gu, Sungnam-city Gyeonggi, South Korea, 13311
- Owner or operator
- Primemed Inc. (10088830)
- Roles
- Exporter to the US
- First device listed
- October 15, 2023
- Registered through
- 2026
- Brand names listed
- Parks Pectus System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 19, 2020 | K191057 | Park's Pectus System | HRS | Substantially Equivalent | Tdm Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 19, 2020. 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.