Data / Medical devices / South Korea / Medyssey Co., Ltd.
Medyssey Co., Ltd.: FDA-registered device maker in Jecheon-si Chungbuk, South Korea, 28 510(k) clearances
Medyssey Co., Ltd. is registered with the FDA (registration 3007485169) in Jecheon-si Chungbuk, South Korea. It lists 12 device types. The FDA files 28 510(k) clearances under its listings, the newest dated June 15, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007485169
- Address
- 129, Hanbang expo-ro Jecheon-si, Chungcheongbuk-do, Jecheon-si Chungbuk, South Korea, 27116
- Owner or operator
- Medyssey Co., Ltd. (10028329)
- Roles
- Manufacturer
- First device listed
- February 12, 2009
- Registered through
- 2026
- Brand names listed
- ARTeMIS Spinal System, Athena Cervical Plate System, Athena III Cervical Plate System, Iliad, Kora and Zenius Spinal System - Hook connector, Medussa-PL Cage, Medyssey Navigation System, Medyssey Surgical instrument, Medyssey Tray 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 |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 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 |
| Posterior Cervical Screw System | NKG | 2 | Manufacturer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | 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 |
|---|---|---|---|---|---|---|
| June 15, 2026 | K260036 | NeckTune 3D SA Cervical Cage | OVE | Substantially Equivalent | Medyssey Co, Ltd. | accessdata.fda.gov |
| April 16, 2025 | K242806 | Medyssey Navigation System | OLO | Substantially Equivalent | Medyssey Co, Ltd. | accessdata.fda.gov |
| August 24, 2023 | K232218 | Zenius Spinal System | NKB | Substantially Equivalent | Medyssey USA, Inc. | accessdata.fda.gov |
| March 7, 2023 | K230301 | Athena III Cervical Plate System | KWQ | Substantially Equivalent | Medyssey USA, Inc. | accessdata.fda.gov |
| December 28, 2022 | K223654 | Medussa-PL Cage | MAX | Substantially Equivalent | Medyssey USA, Inc. | accessdata.fda.gov |
| June 18, 2020 | K200283 | Medussa-PL Cage | MAX | Substantially Equivalent | Medyssey USA, Inc. | accessdata.fda.gov |
| August 30, 2019 | K183407 | Triton Cage | MAX | Substantially Equivalent | Medyssey USA, Inc. | accessdata.fda.gov |
| August 13, 2018 | K181978 | Zenius, Iliad and Kora Spinal Fixation Systems | NKB | Substantially Equivalent | Medyssey USA, Inc. | accessdata.fda.gov |
| July 20, 2018 | K180022 | Athena Cervical Plate System | KWQ | Substantially Equivalent | Medyssey USA, Inc. | accessdata.fda.gov |
| December 14, 2017 | K170389 | TAURUS PEEK Cage System | MAX | Substantially Equivalent | Medyssey USA, Inc. | accessdata.fda.gov |
| December 8, 2017 | K172756 | Varian cage | MAX | Substantially Equivalent | Medyssey USA, Inc. | accessdata.fda.gov |
| November 2, 2017 | K170341 | Medussa-PL Cage | MAX | Substantially Equivalent | Medyssey USA, Inc. | accessdata.fda.gov |
| August 21, 2017 | K171526 | Zenius, lliad and Kora Spinal Fixation Systems | NKB | Substantially Equivalent | Medyssey USA, Inc. | accessdata.fda.gov |
| June 12, 2017 | K171509 | Iliad® Pedicle Screw System and Zenius® Pedicle Screw System | NKB | Substantially Equivalent | Medyssey USA, Inc. | accessdata.fda.gov |
| April 26, 2017 | K170964 | Zenius Spinal System | NKB | Substantially Equivalent | Medyssey USA, Inc. | accessdata.fda.gov |
| January 5, 2017 | K161637 | Poseidon OCT Spinal Fixation System | NKG | Substantially Equivalent | Medyssey USA, Inc. | accessdata.fda.gov |
| June 12, 2015 | K142835 | Iliad Pedicle Screw System and Zenius Pedicle Screw System | NKB | Substantially Equivalent | Medyssey USA, Inc. | accessdata.fda.gov |
| July 18, 2014 | K132732 | MEDYSSEY ANTERIOR CERVICAL FUSION CAGE | ODP | Substantially Equivalent | Medyssey USA, Inc. | accessdata.fda.gov |
| June 5, 2014 | K140564 | BN LUMBAR CAGE SYSTEM | MAX | Substantially Equivalent | Medyssey USA, Inc. | accessdata.fda.gov |
| August 23, 2013 | K131878 | LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | Medyssey USA, Inc. | accessdata.fda.gov |
| January 25, 2013 | K121670 | MEDYSSEY CANNULATED PEDICLE SCREW | NKB | Substantially Equivalent | Medyssey Co, Ltd. | accessdata.fda.gov |
| August 10, 2012 | K121320 | C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE | ODP | Substantially Equivalent | Medyssey Co, Ltd. | accessdata.fda.gov |
| June 8, 2011 | K110284 | NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM | MNI | Substantially Equivalent | Medyssey Co, Ltd. | accessdata.fda.gov |
| April 8, 2011 | K110067 | LP CAGE | MAX | Substantially Equivalent | Medyssey Co, Ltd. | accessdata.fda.gov |
| December 29, 2010 | K103272 | ZENIUS SPINAL SYSTEM | MNI | Substantially Equivalent | Medyssey Co, Ltd. | accessdata.fda.gov |
| December 16, 2010 | K103147 | NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM | MNI | Substantially Equivalent | Medyssey Co, Ltd. | accessdata.fda.gov |
| June 25, 2010 | K093104 | MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM | MNI | Substantially Equivalent | Medyssey Co, Ltd. | accessdata.fda.gov |
| January 30, 2009 | K081153 | NOVEL SPINAL SYSTEM | MNH | Substantially Equivalent | Medyssey Co, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Orthosis, Spinal Pedicle Fixation
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Orthosis, Spondylolisthesis Spinal Fixation
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Intervertebral Fusion Device With Integrated Fixation, Cervical
Updated June 15, 2026. 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.