Medyssey Co, Ltd. FDA Record
- Latest inspection VAI · Jun 19, 2014
- No warning letters matched by name
Medyssey Co, Ltd. has 0 FDA recalls, 1 inspection, 14 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Medyssey Co, Ltd." is on file.
- Latest inspection
- Jun 19, 2014 · VAI
- Latest 510(k)
- Oct 15, 2026
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 14 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 1 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Reviewing Medyssey Co, Ltd. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Medyssey Co, Ltd. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 19, 2014 | Jecheon-Si, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 3007485169 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3007485169 | Jecheon-Si, Korea (The Republic Of) | 1 | Jun 19, 2014 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K262522 | Odys-SI Screw | Oct 15, 2026 |
| K262726 | NeckTune SA Cervical Cage | Sep 29, 2026 |
| K260036 | NeckTune 3D SA Cervical Cage | Jun 15, 2026 |
| K242806 | Medyssey Navigation System | Apr 16, 2025 |
| K121670 | MEDYSSEY CANNULATED PEDICLE SCREW | Jan 25, 2013 |
| K121320 | C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE | Aug 10, 2012 |
| K121246 | MEDYSSY LT CAGE SYSTEM | Jun 15, 2012 |
| K110284 | NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM | Jun 8, 2011 |
| K110283 | ZENIUS SPINAL SYSTEM | May 19, 2011 |
| K110067 | LP CAGE | Apr 8, 2011 |
| K103272 | ZENIUS SPINAL SYSTEM | Dec 29, 2010 |
| K103147 | NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM | Dec 16, 2010 |
| K093104 | MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM | Jun 25, 2010 |
| K081153 | NOVEL SPINAL SYSTEM | Jan 30, 2009 |
Medyssey Co, Ltd. and the FDA: common questions
Has Medyssey Co, Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Medyssey Co, Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Medyssey Co, Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Medyssey Co, Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Medyssey Co, Ltd.?
The most recent FDA inspection on file ended Jun 19, 2014 at Jecheon-Si, Korea (The Republic Of) and was classified VAI. FDA has 1 inspection of Medyssey Co, Ltd. on file.
Need more than this page shows? Ask about Medyssey Co, Ltd. in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.