Medyssey USA, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Medyssey USA, Inc.” (first 2013, latest 2023), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 88 days. Since 2017 the median was 86 days, against 88 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2013 | 1 | 60 |
| 2014 | 2 | 205 |
| 2015 | 1 | 255 |
| 2016 | 0 | — |
| 2017 | 7 | 88 |
| 2018 | 2 | 109 |
| 2019 | 2 | 163 |
| 2020 | 1 | 135 |
| 2021 | 0 | — |
| 2022 | 1 | 22 |
| 2023 | 2 | 30 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medyssey USA, Inc. took a median 86 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 7 | 7 |
| NKB | Thoracolumbosacral Pedicle Screw System | 7 | 7 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 3 | 3 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
Review panels
- Orthopedic (19)
Most recent Medyssey USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232218 | Zenius Spinal System | NKB | 2023-08-24 | 29 |
| K230301 | Athena III Cervical Plate System | KWQ | 2023-03-07 | 32 |
| K223654 | Medussa-PL Cage | MAX | 2022-12-28 | 22 |
| K200283 | Medussa-PL Cage | MAX | 2020-06-18 | 135 |
| K183407 | Triton Cage | MAX | 2019-08-30 | 263 |
| K183409 | Athena II Cervical Plate System | KWQ | 2019-02-11 | 63 |
| K181978 | Zenius, Iliad and Kora Spinal Fixation Systems | NKB | 2018-08-13 | 20 |
| K180022 | Athena Cervical Plate System | KWQ | 2018-07-20 | 198 |
| K170389 | TAURUS PEEK Cage System | MAX | 2017-12-14 | 309 |
| K172756 | Varian cage | MAX | 2017-12-08 | 86 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medyssey USA, Inc..
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 Co, Ltd. (12 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medyssey USA, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Medyssey USA, Inc.” (first 2013, latest 2023), across 5 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 USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medyssey USA, Inc. is 88 days. Since 2017: 86 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medyssey USA, Inc.?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 7); NKB (Thoracolumbosacral Pedicle Screw System, 7); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 3).
Next steps
- See all 19 Medyssey USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MAX, Medyssey USA, Inc.'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.