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 | 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 | AIRLOCK SP023010 | 2023-09-04 |
| NOVASTEP | AIRLOCK SP023008 | 2023-09-04 |
| NOVASTEP | AIRLOCK SP013030 | 2023-09-04 |
| NOVASTEP | AIRLOCK SP013028 | 2023-09-04 |
| NOVASTEP | AIRLOCK SP013026 | 2023-09-04 |
| NOVASTEP | AIRLOCK SP013024 | 2023-09-04 |
| NOVASTEP | AIRLOCK SP013022 | 2023-09-04 |
| NOVASTEP | AIRLOCK SP013020 | 2023-09-04 |
| NOVASTEP | AIRLOCK SP013018 | 2023-09-04 |
| NOVASTEP | AIRLOCK SP013016 | 2023-09-04 |
| NOVASTEP | AIRLOCK SP013014 | 2023-09-04 |
| NOVASTEP | AIRLOCK SP013012 | 2023-09-04 |
| NOVASTEP | AIRLOCK SP013010 | 2023-09-04 |
| NOVASTEP | AIRLOCK SP013008 | 2023-09-04 |
| NOVASTEP | NEXIS SC050060 | 2023-09-04 |
| NOVASTEP | NEXIS SC050055 | 2023-09-04 |
| NOVASTEP | NEXIS SC050050 | 2023-09-04 |
| NOVASTEP | NEXIS SC050048 | 2023-09-04 |
| NOVASTEP | NEXIS SC050046 | 2023-09-04 |
| NOVASTEP | NEXIS SC050044 | 2023-09-04 |
| NOVASTEP | NEXIS SC050042 | 2023-09-04 |
| NOVASTEP | NEXIS SC050040 | 2023-09-04 |
| NOVASTEP | NEXIS SC050038 | 2023-09-04 |
| NOVASTEP | NEXIS SC050036 | 2023-09-04 |
| NOVASTEP | NEXIS SC050034 | 2023-09-04 |
| NOVASTEP | NEXIS SC050032 | 2023-09-04 |
| NOVASTEP | NEXIS SC050030 | 2023-09-04 |
| NOVASTEP | NEXIS SC050028 | 2023-09-04 |
| NOVASTEP | NEXIS SC050026 | 2023-09-04 |
| NOVASTEP | NEXIS SC050024 | 2023-09-04 |
| NOVASTEP | NEXIS SC050022 | 2023-09-04 |
| NOVASTEP | NEXIS SC050020 | 2023-09-04 |
| NOVASTEP | NEXIS SC050018 | 2023-09-04 |
| NOVASTEP | NEXIS SC020034 | 2023-09-04 |
| NOVASTEP | NEXIS SC020032 | 2023-09-04 |
| NOVASTEP | ARCAD XFP03006 | 2023-09-04 |
| NOVASTEP | ARCAD XFP03005 | 2023-09-04 |
| NOVASTEP | ARCAD XFP03004 | 2023-09-04 |
| NOVASTEP | ARCAD XFP03003 | 2023-09-04 |
| NOVASTEP | ARCAD XFP03002 | 2023-09-04 |
| NOVASTEP | LYNC XTR00005 | 2023-09-04 |
| NOVASTEP | NEXIS CKW01008 | 2023-09-04 |
| NOVASTEP | ARCAD XFP03001 | 2023-09-04 |
| NOVASTEP | LYNC CM010021 | 2023-09-04 |
| NOVASTEP | LYNC CM010020 | 2023-09-04 |
| NOVASTEP | LYNC CM010011 | 2023-09-04 |
| NOVASTEP | LYNC CM010010 | 2023-09-04 |
| NOVASTEP | NEXIS SC040016 | 2023-09-04 |
| NOVASTEP | NEXIS SC040015 | 2023-09-04 |
| NOVASTEP | NEXIS SC040014 | 2023-09-04 |
| NOVASTEP | NEXIS SC040013 | 2023-09-04 |
| NOVASTEP | NEXIS SC040012 | 2023-09-04 |
| NOVASTEP | NEXIS SC040011 | 2023-09-04 |
| NOVASTEP | NEXIS SC030024 | 2023-09-04 |
| NOVASTEP | NEXIS SC030022 | 2023-09-04 |
| NOVASTEP | NEXIS SC030020 | 2023-09-04 |
| NOVASTEP | NEXIS SC030018 | 2023-09-04 |
| NOVASTEP | NEXIS SC030016 | 2023-09-04 |
| NOVASTEP | NEXIS SC030014 | 2023-09-04 |
| NOVASTEP | NEXIS SC020030 | 2023-09-04 |
| NOVASTEP | NEXIS SC020028 | 2023-09-04 |
| NOVASTEP | NEXIS SC020026 | 2023-09-04 |
| NOVASTEP | NEXIS SC020024 | 2023-09-04 |
| NOVASTEP | NEXIS SC020022 | 2023-09-04 |
| NOVASTEP | NEXIS SC020020 | 2023-09-04 |
| NOVASTEP | NEXIS SC020018 | 2023-09-04 |
| NOVASTEP | NEXIS SC020016 | 2023-09-04 |
| NOVASTEP | NEXIS SC020014 | 2023-09-04 |
| NOVASTEP | NEXIS SC020012 | 2023-09-04 |
| NOVASTEP | NEXIS SC020010 | 2023-09-04 |
| NOVASTEP | NEXIS SC010030 | 2023-09-04 |
| NOVASTEP | NEXIS SC010028 | 2023-09-04 |
| 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 |