This page includes the latest FDA filings for Novastep. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Novastep holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 3010673777 |
| FEI Number | 3010673777 |
| Name | GUREVICH Vadim |
| Owner & Operator | NOVASTEP |
| Contact Address | ESPACE PERFORMANCE III Batiment P SAINT GREGOIRE FR-E Bretagne 35769 FR |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 30 Ramland Road Suite 200 Orangeburg, NY 10962 US |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| NOVASTEP | XSD11001 XSD11001 | 2025-09-30 |
| NOVASTEP | ACC1024P0002 ACC1024P0002 | 2025-09-30 |
| NOVASTEP | ACC1024P0001 ACC1024P0001 | 2025-09-30 |
| NOVASTEP | SKW01025 SKW01025 | 2025-09-30 |
| NOVASTEP | CKW01025 CKW01025 | 2025-09-30 |
| NOVASTEP | XMS01052-3 XMS01052-3 | 2025-09-30 |
| NOVASTEP | CRE23030 CRE23030 | 2025-09-30 |
| NOVASTEP | SKW08003 SKW08003 | 2025-09-30 |
| NOVASTEP | CKW08003 CKW08003 | 2025-09-30 |
| NOVASTEP | XMS01054 XMS01054 | 2025-09-30 |
| NOVASTEP | XMS01053-1 XMS01053-1 | 2025-09-30 |
| NOVASTEP | XMS01052-1 XMS01052-1 | 2025-09-30 |
| NOVASTEP | XMS01051 XMS01051 | 2025-09-30 |
| NOVASTEP | SKW08004 SKW08004 | 2025-09-30 |
| NOVASTEP | CKW08004 CKW08004 | 2025-09-30 |
| NOVASTEP | PECA® 2.0 XDG01037 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 XDG01036 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 XMS01038-8 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 XDG01035 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 XDG01034 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 XDG01033 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 XDB01029D | 2025-06-25 |
| NOVASTEP | PECA® 2.0 XDB01029 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 XDB01028 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 XSD10001 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 XSD10002 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 XRE01026 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 XDB01031D | 2025-06-25 |
| NOVASTEP | PECA® 2.0 XDB01031 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 XDB01030 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS070048 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS070046 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS070044 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS070042 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS070040 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS070038 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS070036 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS070034 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS070032 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS070030 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS070028 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS060060 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS060058 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS060056 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS060054 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS060052 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS060050 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS060048 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS060046 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS060044 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS060042 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS060040 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS060038 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS060036 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS060034 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS060032 | 2025-06-25 |
| NOVASTEP | PECA®2.0 PS060030 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS060028 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS060026 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 XSD09002 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 XSD09001 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS070026 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS070024 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS070022 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS070020 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS070018 | 2025-06-25 |
| NOVASTEP | PECA® 2.0 PS070016 | 2025-06-25 |
| NOVASTEP | Tarsoplasty® SKW05006 | 2025-02-07 |
| NOVASTEP | CKW05006 CKW05006 | 2025-02-07 |
| NOVASTEP | PECAPLASTY® XMS01050 | 2025-01-23 |
| NOVASTEP | airlock® SKW09001 | 2025-01-21 |
| NOVASTEP | airlock® CKW09001 | 2025-01-21 |
| NOVASTEP | Tarsoplasty® SKW05005 | 2024-09-20 |
| NOVASTEP | SKW01022 SKW01022 | 2024-09-20 |
| NOVASTEP | arcad® 2.0 CSK101012 | 2024-08-16 |
| NOVASTEP | Tarsoplasty® XMS01041-6 | 2024-08-15 |
| NOVASTEP | CKW05005 CKW05005 | 2024-08-15 |
| NOVASTEP | CKW01022 CKW01022 | 2024-08-15 |
| NOVASTEP | arcad® 2.0 XFP01013 | 2024-04-24 |
| NOVASTEP | arcad® 2.0 SUI09001 | 2024-04-24 |
| NOVASTEP | arcad® 2.0 CSK301612 | 2024-04-24 |
| NOVASTEP | arcad® 2.0 CSK302020 | 2024-04-24 |
| NOVASTEP | arcad® 2.0 CSK261818 | 2024-04-24 |
| NOVASTEP | arcad® 2.0 CSK252020 | 2024-04-24 |
| NOVASTEP | arcad® 2.0 CSK202020 | 2024-04-24 |
| NOVASTEP | arcad® 2.0 CSK181818 | 2024-04-24 |
| NOVASTEP | arcad® 2.0 CSK151515 | 2024-04-24 |
| NOVASTEP | arcad® 2.0 CSK121212 | 2024-04-24 |
| NOVASTEP | nexis® XRE01008D | 2024-02-16 |
| NOVASTEP | nexis/arcad® ACC1001P0016 | 2023-12-28 |
| NOVASTEP | - XFP01004 | 2023-12-28 |
| NOVASTEP | NEXIS SC010026 | 2023-09-04 |
| NOVASTEP | NEXIS SC010024 | 2023-09-04 |
| NOVASTEP | NEXIS SC010022 | 2023-09-04 |
| NOVASTEP | NEXIS SC010020 | 2023-09-04 |
| NOVASTEP | NEXIS SC010018 | 2023-09-04 |
| NOVASTEP | NEXIS SC010016 | 2023-09-04 |
| NOVASTEP | NEXIS SC010014 | 2023-09-04 |
| NOVASTEP | NEXIS SC010012 | 2023-09-04 |
| NOVASTEP | NEXIS SC010010 | 2023-09-04 |
GUREVICH Vadim [NOVASTEP] | Centrolock? osteosynthesis implant system | 2019-12-17 |
NOVASTEP | Airlock Centrolock Osteosynthesis Implant System | 2019-12-14 |
GUREVICH Vadim [NOVASTEP] | Novastep Tray | 2018-05-15 |
GUREVICH Vadim [NOVASTEP] | Airlock osteosynthesis plate system | 2015-08-18 |
NOVASTEP | Airlock® Osteosynthesis Plate System | 2015-08-13 |
GUREVICH Vadim [NOVASTEP] | Airlock Bone Plate System | 2015-04-07 |
NOVASTEP | Airlock Osteosynthesis Plate System | 2015-04-06 |
GUREVICH Vadim [NOVASTEP] | Lync intramedullary implant | 2015-02-20 |
NOVASTEP | LYNC Intramedullary Implant | 2015-02-19 |
GUREVICH Vadim [NOVASTEP] | Nexis? osteosynthesis compressive screws | 2015-02-09 |
GUREVICH Vadim [NOVASTEP] | Nexis? osteosynthesis snap-off screws | 2015-02-09 |
NOVASTEP | Nexis Osteosynthesis Compressive Screws | 2015-02-06 |
NOVASTEP | Nexis Osteosynthesis Snap-off Screws | 2015-02-06 |
GUREVICH Vadim [NOVASTEP] | Novastep orthopedic manual surgical instrument | 2014-12-24 |
GUREVICH Vadim [NOVASTEP] | Novastep Instrument, surgical, orthopedic, AC powered motor and Accessory/attachement | 2014-12-24 |
GUREVICH Vadim [NOVASTEP] | Arcad compressive osteosynthesis staples | 2014-12-23 |