Data / Medical devices / South Korea / Organ Eco Tech
Organ Eco Tech: FDA-registered device maker in Seongnam-Si Gyeonggi, South Korea, 12 510(k) clearances
Organ Eco Tech is registered with the FDA (registration 3008526708) in Seongnam-Si Gyeonggi, South Korea. It lists 11 device types. The FDA files 12 510(k) clearances under its listings, the newest dated May 5, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008526708
- Address
- # Megacenter, SKn technopark 124 Sagimakgol-ro, Jungwon-gu, Seongnam-Si Gyeonggi, South Korea, 13207
- Owner or operator
- Organ Eco Tech Co., Ltd. (10033497)
- Roles
- Manufacturer
- First device listed
- April 17, 2012
- Registered through
- 2026
- Brand names listed
- AEON-C" Stand Alone System, Balteum" Lumbar Plate System, FaSet Fixation System, Fortis & Hana Anterior Cervical Plate System, Huvex Interspinous Fixation System, IVA INTERBODY FUSION CAGE SYSTEM, IVA Intervertebral Titanium Fusion Cage System, REXIOUS HOOK FIXATION SYSTEMS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Manufacturer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Manufacturer | accessdata.fda.gov |
| Sacroiliac Joint Fixation | OUR | 2 | Manufacturer | accessdata.fda.gov |
| Spinous Process Plate | PEK | 2 | Manufacturer | accessdata.fda.gov |
| System, Facet Screw Spinal Device | MRW | U | 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 |
|---|---|---|---|---|---|---|
| May 5, 2020 | K200846 | Balteum Lumbar Plate System | KWQ | Substantially Equivalent | Huvexel Co. , Ltd. | accessdata.fda.gov |
| November 13, 2019 | K191477 | AEON-C Stand Alone System | OVE | Substantially Equivalent | Huvexel Co. , Ltd. | accessdata.fda.gov |
| June 28, 2018 | K180729 | FaSet Fixation System | MRW | Substantially Equivalent | Huvexel Co. , Ltd. | accessdata.fda.gov |
| April 26, 2018 | K173201 | UNITY Sacroiliac Joint Fixation System | OUR | Substantially Equivalent | Huvexel Co. , Ltd. | accessdata.fda.gov |
| December 8, 2017 | K173131 | Rexious Spinal Fixation System | NKB | Substantially Equivalent | Huvexel Co. , Ltd. | accessdata.fda.gov |
| November 30, 2017 | K173099 | Fortis and Hana Anterior Cervical Plate System | KWQ | Substantially Equivalent | Huvexel Co. , Ltd. | accessdata.fda.gov |
| October 31, 2017 | K173080 | IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) | MAX | Substantially Equivalent | Huvexel Co. , Ltd. | accessdata.fda.gov |
| February 16, 2017 | K162849 | Huvex Interspinous Fixation System | PEK | Substantially Equivalent | Dio Medical Co., Ltd. | accessdata.fda.gov |
| November 21, 2016 | K162220 | DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage | ODP | Substantially Equivalent | Dio Medical Co., Ltd. | accessdata.fda.gov |
| November 20, 2012 | K122229 | VICEROY SPINAL SYSTEM | NKB | Substantially Equivalent | Torrey Spine | accessdata.fda.gov |
| October 31, 2012 | K121862 | REX ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Dio Medical Co., Ltd. | accessdata.fda.gov |
| March 28, 2012 | K113324 | REXIOUS HOOK FIXATION SYSTEMS | KWP | Substantially Equivalent | Dio Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Orthosis, Spinal Pedicle Fixation
- All makers of Orthosis, Spondylolisthesis Spinal Fixation
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Appliance, Fixation, Spinal Intervertebral Body
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
Updated May 5, 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.