Data / Medical devices / South Korea / Solendos., Inc.
Solendos., Inc.: FDA-registered device maker in GURO-GU Seoul, South Korea, 1 510(k) clearance
Solendos., Inc. is registered with the FDA (registration 3027262786) in GURO-GU Seoul, South Korea. It lists 10 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 18, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027262786
- Address
- #503 5F, E&c Venture Dream Tower3 38-21 Digital-Ro 31 Gil,, Guro-Gu, Seoul, GURO-GU Seoul, South Korea, 08376
- Owner or operator
- Solendos., INC. (10089428)
- Roles
- Repackager or relabeler
- First device listed
- December 7, 2023
- Registered through
- 2026
- Brand names listed
- TA119-100, TA119-130, TA127-100, TA127-130, TA240-100, TA240-130, TA240-170, TA340-100 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Arthroscope | HRX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Chisel, Surgical, Manual | FZO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Surgical, General Use | FZS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Elevator, Surgical, General & Plastic Surgery | GEG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Knife, Orthopedic | HTS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mallet | HXL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Punch, Surgical | LRY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor | GAD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rongeur | HTX | 1 | Repackager or relabeler | 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 18, 2008 | K080560 | HENKE SASS WOLF OF AMERICA ARTHROSCOPE | HRX | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Chisel, Surgical, Manual
- All makers of Mallet
- All makers of Retractor
- All makers of Elevator, Surgical, General & Plastic Surgery
- All makers of Arthroscope
- All makers of Curette, Surgical, General Use
Updated March 18, 2008. 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.