Medyssey Co, Ltd.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Medyssey Co, Ltd.” (first 2009, latest 2026), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 117 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 76 |
| 2013 | 1 | 233 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 211 |
| 2026 | 1 | 160 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medyssey Co, Ltd. took a median 186 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation | 5 | 5 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 | 1 |
Review panels
- Orthopedic (12)
Most recent Medyssey Co, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260036 | NeckTune 3D SA Cervical Cage | OVE | 2026-06-15 | 160 |
| K242806 | Medyssey Navigation System | OLO | 2025-04-16 | 211 |
| K121670 | MEDYSSEY CANNULATED PEDICLE SCREW | NKB | 2013-01-25 | 233 |
| K121320 | C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE | ODP | 2012-08-10 | 100 |
| K121246 | MEDYSSY LT CAGE SYSTEM | MAX | 2012-06-15 | 51 |
| K110284 | NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM | MNI | 2011-06-08 | 127 |
| K110283 | ZENIUS SPINAL SYSTEM | MNI | 2011-05-19 | 107 |
| K110067 | LP CAGE | MAX | 2011-04-08 | 88 |
| K103272 | ZENIUS SPINAL SYSTEM | MNI | 2010-12-29 | 54 |
| K103147 | NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM | MNI | 2010-12-16 | 52 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medyssey Co, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medyssey USA, Inc. (19 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medyssey Co, Ltd.?
FDA lists 12 510(k) clearances under the applicant name “Medyssey Co, Ltd.” (first 2009, latest 2026), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medyssey Co, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medyssey Co, Ltd. is 117 days.
Which FDA product codes appear under Medyssey Co, Ltd.?
The most frequent FDA product codes under this applicant name are MNI (Orthosis, Spinal Pedicle Fixation, 5); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2); MNH (Orthosis, Spondylolisthesis Spinal Fixation, 1).
Next steps
- See all 12 Medyssey Co, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MNI, Medyssey Co, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.