Novastep
RENNES Bretagne, FR
NOVASTEP appears in FDA device records in RENNES Bretagne, FR. FDA records list 8 510(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 8 510(k) clearances for Novastep between 2015 and 2023. The busiest year on record is 2015, with 5. The most recent is 2023, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 5 |
| 2019 | 1 |
| 2023 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staples | JDR | Substantially Equivalent | |
| K223468 | Nexis® compressive screws | HWC | Substantially Equivalent | |
| K192356 | Airlock Centrolock Osteosynthesis Implant System | HRS | Substantially Equivalent | |
| K151277 | Airlock® osteosynthesis plate system | HRS | Substantially Equivalent | |
| K143523 | Airlock osteosynthesis plate system | HRS | Substantially Equivalent | |
| K143049 | LYNC intramedullary implant | HTY | Substantially Equivalent | |
| K143229 | Nexis osteosynthesis compressive screws | HWC | Substantially Equivalent | |
| K143146 | Nexis osteosynthesis snap-off screws | HWC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010673777 | 3010673777 | NOVASTEP | 2 allee Jacques Frimot, RENNES Bretagne 35000 FR | 2026 |
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