Data / Medical devices / South Korea / Taeyeon Medical Co., Ltd.
Taeyeon Medical Co., Ltd.: FDA-registered device maker in Wonju-si Gangwon, South Korea, 3 510(k) clearances
Taeyeon Medical Co., Ltd. is registered with the FDA (registration 3011489618) in Wonju-si Gangwon, South Korea. It lists 9 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 15, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011489618
- Address
- 132-1 Donghwagongdan-Ro, Munmak-eup, Wonju-si Gangwon, South Korea, 26365
- Owner or operator
- TAEYEON MEDICAL Co., Ltd. (10089805)
- Roles
- Manufacturer
- First device listed
- January 9, 2024
- Registered through
- 2026
- Brand names listed
- 4S Spinal System, Balex Bone Expander System, Dyflex-II, PCD System, TVP SYSTEM
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Manufacturer | accessdata.fda.gov |
| Arthroscope | HRX | 2 | Manufacturer | accessdata.fda.gov |
| Cement, Bone, Vertebroplasty | NDN | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Manufacturer | accessdata.fda.gov |
| Spinal Channeling Instrument, Vertebroplasty | OCJ | 1 | Manufacturer | accessdata.fda.gov |
| Tamp | HXG | 1 | Manufacturer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| November 15, 2022 | K212700 | Dyflex-II | NKB | Substantially Equivalent | Taeyeon Medical Co., Ltd. | accessdata.fda.gov |
| February 3, 2021 | K202027 | Balex bone Expander System | HRX | Substantially Equivalent | Taeyeon Medical Co., Ltd. | accessdata.fda.gov |
| April 24, 2007 | K063708 | 4S SPINAL SYSTEM | MNI | Substantially Equivalent | Taeyeon Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Appliance, Fixation, Spinal Intervertebral Body
- All makers of Orthosis, Spinal Pedicle Fixation
- All makers of Orthosis, Spondylolisthesis Spinal Fixation
- All makers of Cement, Bone, Vertebroplasty
- All makers of Tamp
- All makers of Arthroscope
Updated November 15, 2022. 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.