Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Medyssey USA, Inc. with 19 510(k) clearances. The most recent is a 510(k) clearance dated Aug 24, 2023: Zenius™ Spinal System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 24, 2023 | Zenius™ Spinal SystemK232218 · NKB | 510(k) clearances |
| Mar 7, 2023 | Athena III Cervical Plate SystemK230301 · KWQ | 510(k) clearances |
| Dec 28, 2022 | Medussa-PL CageK223654 · MAX | 510(k) clearances |
| Jun 18, 2020 | Medussa-PL CageK200283 · MAX | 510(k) clearances |
| Aug 30, 2019 | Triton CageK183407 · MAX | 510(k) clearances |
| Feb 11, 2019 | Athena II Cervical Plate SystemK183409 · KWQ | 510(k) clearances |
| Aug 13, 2018 | Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsK181978 · NKB | 510(k) clearances |
| Jul 20, 2018 | Athena Cervical Plate SystemK180022 · KWQ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
