Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medyssey USA, Inc. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
309 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232218 | Zenius™ Spinal System | Medyssey USA, Inc. | 2023-08-24 | 29 | 0 |
| K230301 | Athena III Cervical Plate System | Medyssey USA, Inc. | 2023-03-07 | 32 | 0 |
| K223654 | Medussa-PL Cage | Medyssey USA, Inc. | 2022-12-28 | 22 | 0 |
| K200283 | Medussa-PL Cage | Medyssey USA, Inc. | 2020-06-18 | 135 | 0 |
| K183407 | Triton Cage | Medyssey USA, Inc. | 2019-08-30 | 263 | 0 |
| K183409 | Athena II Cervical Plate System | Medyssey USA, Inc. | 2019-02-11 | 63 | 0 |
| K181978 | Zenius™, Iliad™ and Kora™ Spinal Fixation Systems | Medyssey USA, Inc. | 2018-08-13 | 20 | 0 |
| K180022 | Athena Cervical Plate System | Medyssey USA, Inc. | 2018-07-20 | 198 | 0 |
| K170389 | TAURUS PEEK Cage System | Medyssey USA, Inc. | 2017-12-14 | 309 | 0 |
| K172756 | Varian cage | Medyssey USA, Inc. | 2017-12-08 | 86 | 0 |
| K170341 | Medussa-PL Cage | Medyssey USA, Inc. | 2017-11-02 | 272 | 0 |
| K171526 | Zenius™, lliad™ and Kora™ Spinal Fixation Systems | Medyssey USA, Inc. | 2017-08-21 | 88 | 0 |
| K171509 | Iliad® Pedicle Screw System and Zenius® Pedicle Screw System | Medyssey USA, Inc. | 2017-06-12 | 20 | 0 |
| K170964 | Zenius Spinal System | Medyssey USA, Inc. | 2017-04-26 | 26 | 0 |
| K161637 | Poseidon OCT Spinal Fixation System | Medyssey USA, Inc. | 2017-01-05 | 205 | 0 |
| K142835 | Iliad Pedicle Screw System and Zenius Pedicle Screw System | Medyssey USA, Inc. | 2015-06-12 | 255 | 0 |
| K132732 | MEDYSSEY ANTERIOR CERVICAL FUSION CAGE | Medyssey USA, Inc. | 2014-07-18 | 318 | 0 |
| K140564 | BN LUMBAR CAGE SYSTEM | Medyssey USA, Inc. | 2014-06-05 | 92 | 0 |
| K131878 | LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM | Medyssey USA, Inc. | 2013-08-23 | 60 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda