Medyssey Co., Ltd.
Jecheon-si Chungbuk, KR
MEDYSSEY CO., LTD. appears in FDA device records in Jecheon-si Chungbuk, KR. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Medyssey Co., Ltd. between 2009 and 2026. The busiest year on record is 2010, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2010 | 3 |
| 2011 | 3 |
| 2012 | 2 |
| 2013 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260036 | NeckTune™ 3D SA Cervical Cage | OVE | Substantially Equivalent | |
| K242806 | Medyssey Navigation System | OLO | Substantially Equivalent | |
| K121670 | MEDYSSEY CANNULATED PEDICLE SCREW | NKB | Substantially Equivalent | |
| K121320 | C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE | ODP | Substantially Equivalent | |
| K121246 | MEDYSSY LT CAGE SYSTEM | MAX | Substantially Equivalent | |
| K110284 | NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM | MNI | Substantially Equivalent | |
| K110283 | ZENIUS SPINAL SYSTEM | MNI | Substantially Equivalent | |
| K110067 | LP CAGE | MAX | Substantially Equivalent | |
| K103272 | ZENIUS SPINAL SYSTEM | MNI | Substantially Equivalent | |
| K103147 | NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM | MNI | Substantially Equivalent | |
| K093104 | MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM | MNI | Substantially Equivalent | |
| K081153 | NOVEL SPINAL SYSTEM | MNH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007485169 | 3007485169 | MEDYSSEY CO., LTD. | 129, Hanbang expo-ro, Jecheon-si Chungbuk 27116 KR | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- OARInjector, Vertebroplasty (Does Not Contain Cement)
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- NKGPosterior Cervical Screw System
- NKBThoracolumbosacral Pedicle Screw System
- LRPTray, Surgical
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Medyssey Co., Ltd. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain