Medyssey USA
Rancho California, CA, US
Medyssey USA appears in FDA device records in Rancho California, CA. FDA records list 19 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 19 510(k) clearances for Medyssey USA between 2013 and 2023. The busiest year on record is 2017, with 7. The most recent is 2023, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 1 |
| 2017 | 7 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232218 | Zenius™ Spinal System | NKB | Substantially Equivalent | |
| K230301 | Athena III Cervical Plate System | KWQ | Substantially Equivalent | |
| K223654 | Medussa-PL Cage | MAX | Substantially Equivalent | |
| K200283 | Medussa-PL Cage | MAX | Substantially Equivalent | |
| K183407 | Triton Cage | MAX | Substantially Equivalent | |
| K183409 | Athena II Cervical Plate System | KWQ | Substantially Equivalent | |
| K181978 | Zenius™, Iliad™ and Kora™ Spinal Fixation Systems | NKB | Substantially Equivalent | |
| K180022 | Athena Cervical Plate System | KWQ | Substantially Equivalent | |
| K170389 | TAURUS PEEK Cage System | MAX | Substantially Equivalent | |
| K172756 | Varian cage | MAX | Substantially Equivalent | |
| K170341 | Medussa-PL Cage | MAX | Substantially Equivalent | |
| K171526 | Zenius™, lliad™ and Kora™ Spinal Fixation Systems | NKB | Substantially Equivalent | |
| K171509 | Iliad® Pedicle Screw System and Zenius® Pedicle Screw System | NKB | Substantially Equivalent | |
| K170964 | Zenius Spinal System | NKB | Substantially Equivalent | |
| K161637 | Poseidon OCT Spinal Fixation System | NKG | Substantially Equivalent | |
| K142835 | Iliad Pedicle Screw System and Zenius Pedicle Screw System | NKB | Substantially Equivalent | |
| K132732 | MEDYSSEY ANTERIOR CERVICAL FUSION CAGE | ODP | Substantially Equivalent | |
| K140564 | BN LUMBAR CAGE SYSTEM | MAX | Substantially Equivalent | |
| K131878 | LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008692185 | 3008692185 | Medyssey USA | 43176 Business Park Dr Ste 107 Temecula, Rancho California, CA 92590 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain