Novastep

FDA Filings

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:

FDA Registration(s)
Registration Number3010673777
FEI Number3010673777
NameGUREVICH Vadim
Owner & OperatorNOVASTEP
Contact AddressESPACE PERFORMANCE III Batiment P
SAINT GREGOIRE FR-E Bretagne 35769 FR
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address30 Ramland Road Suite 200
Orangeburg, NY 10962 US
Establishment TypeManufacture Medical Device



FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
NOVASTEP
nexis® XRE01008D2024-02-16
NOVASTEP
nexis/arcad® ACC1001P00162023-12-28
NOVASTEP
- XFP010042023-12-28
NOVASTEP
AIRLOCK SP0135122023-09-04
NOVASTEP
AIRLOCK SP0135102023-09-04
NOVASTEP
AIRLOCK SP0135082023-09-04
NOVASTEP
NEXIS XTR000092023-09-04
NOVASTEP
AIRLOCK PL0101402023-09-04
NOVASTEP
AIRLOCK PL0102402023-09-04
NOVASTEP
AIRLOCK SP0230302023-09-04
NOVASTEP
AIRLOCK SP0230282023-09-04
NOVASTEP
AIRLOCK SP0230262023-09-04
NOVASTEP
AIRLOCK SP0230242023-09-04
NOVASTEP
AIRLOCK SP0230222023-09-04
NOVASTEP
AIRLOCK SP0230202023-09-04
NOVASTEP
AIRLOCK SP0230182023-09-04
NOVASTEP
AIRLOCK SP0230162023-09-04
NOVASTEP
AIRLOCK SP0230142023-09-04
NOVASTEP
AIRLOCK SP0230122023-09-04
NOVASTEP
AIRLOCK SP0230102023-09-04
NOVASTEP
AIRLOCK SP0230082023-09-04
NOVASTEP
AIRLOCK SP0130302023-09-04
NOVASTEP
AIRLOCK SP0130282023-09-04
NOVASTEP
AIRLOCK SP0130262023-09-04
NOVASTEP
AIRLOCK SP0130242023-09-04
NOVASTEP
AIRLOCK SP0130222023-09-04
NOVASTEP
AIRLOCK SP0130202023-09-04
NOVASTEP
AIRLOCK SP0130182023-09-04
NOVASTEP
AIRLOCK SP0130162023-09-04
NOVASTEP
AIRLOCK SP0130142023-09-04
NOVASTEP
AIRLOCK SP0130122023-09-04
NOVASTEP
AIRLOCK SP0130102023-09-04
NOVASTEP
AIRLOCK SP0130082023-09-04
NOVASTEP
NEXIS SC0500602023-09-04
NOVASTEP
NEXIS SC0500552023-09-04
NOVASTEP
NEXIS SC0500502023-09-04
NOVASTEP
NEXIS SC0500482023-09-04
NOVASTEP
NEXIS SC0500462023-09-04
NOVASTEP
NEXIS SC0500442023-09-04
NOVASTEP
NEXIS SC0500422023-09-04
NOVASTEP
NEXIS SC0500402023-09-04
NOVASTEP
NEXIS SC0500382023-09-04
NOVASTEP
NEXIS SC0500362023-09-04
NOVASTEP
NEXIS SC0500342023-09-04
NOVASTEP
NEXIS SC0500322023-09-04
NOVASTEP
NEXIS SC0500302023-09-04
NOVASTEP
NEXIS SC0500282023-09-04
NOVASTEP
NEXIS SC0500262023-09-04
NOVASTEP
NEXIS SC0500242023-09-04
NOVASTEP
NEXIS SC0500222023-09-04
NOVASTEP
NEXIS SC0500202023-09-04
NOVASTEP
NEXIS SC0500182023-09-04
NOVASTEP
NEXIS SC0200342023-09-04
NOVASTEP
NEXIS SC0200322023-09-04
NOVASTEP
ARCAD XFP030062023-09-04
NOVASTEP
ARCAD XFP030052023-09-04
NOVASTEP
ARCAD XFP030042023-09-04
NOVASTEP
ARCAD XFP030032023-09-04
NOVASTEP
ARCAD XFP030022023-09-04
NOVASTEP
LYNC XTR000052023-09-04
NOVASTEP
NEXIS CKW010082023-09-04
NOVASTEP
ARCAD XFP030012023-09-04
NOVASTEP
LYNC CM0100212023-09-04
NOVASTEP
LYNC CM0100202023-09-04
NOVASTEP
LYNC CM0100112023-09-04
NOVASTEP
LYNC CM0100102023-09-04
NOVASTEP
NEXIS SC0400162023-09-04
NOVASTEP
NEXIS SC0400152023-09-04
NOVASTEP
NEXIS SC0400142023-09-04
NOVASTEP
NEXIS SC0400132023-09-04
NOVASTEP
NEXIS SC0400122023-09-04
NOVASTEP
NEXIS SC0400112023-09-04
NOVASTEP
NEXIS SC0300242023-09-04
NOVASTEP
NEXIS SC0300222023-09-04
NOVASTEP
NEXIS SC0300202023-09-04
NOVASTEP
NEXIS SC0300182023-09-04
NOVASTEP
NEXIS SC0300162023-09-04
NOVASTEP
NEXIS SC0300142023-09-04
NOVASTEP
NEXIS SC0200302023-09-04
NOVASTEP
NEXIS SC0200282023-09-04
NOVASTEP
NEXIS SC0200262023-09-04
NOVASTEP
NEXIS SC0200242023-09-04
NOVASTEP
NEXIS SC0200222023-09-04
NOVASTEP
NEXIS SC0200202023-09-04
NOVASTEP
NEXIS SC0200182023-09-04
NOVASTEP
NEXIS SC0200162023-09-04
NOVASTEP
NEXIS SC0200142023-09-04
NOVASTEP
NEXIS SC0200122023-09-04
NOVASTEP
NEXIS SC0200102023-09-04
NOVASTEP
NEXIS SC0100302023-09-04
NOVASTEP
NEXIS SC0100282023-09-04
NOVASTEP
NEXIS SC0100262023-09-04
NOVASTEP
NEXIS SC0100242023-09-04
NOVASTEP
NEXIS SC0100222023-09-04
NOVASTEP
NEXIS SC0100202023-09-04
NOVASTEP
NEXIS SC0100182023-09-04
NOVASTEP
NEXIS SC0100162023-09-04
NOVASTEP
NEXIS SC0100142023-09-04
NOVASTEP
NEXIS SC0100122023-09-04
NOVASTEP
NEXIS SC0100102023-09-04
GUREVICH Vadim [NOVASTEP]
Centrolock? osteosynthesis implant system2019-12-17
NOVASTEP
Airlock Centrolock Osteosynthesis Implant System2019-12-14
GUREVICH Vadim [NOVASTEP]
Novastep Tray2018-05-15
GUREVICH Vadim [NOVASTEP]
Airlock osteosynthesis plate system2015-08-18
NOVASTEP
Airlock® Osteosynthesis Plate System2015-08-13
GUREVICH Vadim [NOVASTEP]
Airlock Bone Plate System2015-04-07
NOVASTEP
Airlock Osteosynthesis Plate System2015-04-06
GUREVICH Vadim [NOVASTEP]
Lync intramedullary implant2015-02-20
NOVASTEP
LYNC Intramedullary Implant2015-02-19
GUREVICH Vadim [NOVASTEP]
Nexis? osteosynthesis compressive screws2015-02-09
GUREVICH Vadim [NOVASTEP]
Nexis? osteosynthesis snap-off screws2015-02-09
NOVASTEP
Nexis Osteosynthesis Compressive Screws2015-02-06
NOVASTEP
Nexis Osteosynthesis Snap-off Screws2015-02-06
GUREVICH Vadim [NOVASTEP]
Novastep orthopedic manual surgical instrument2014-12-24
GUREVICH Vadim [NOVASTEP]
Novastep Instrument, surgical, orthopedic, AC powered motor and Accessory/attachement2014-12-24
GUREVICH Vadim [NOVASTEP]
Arcad compressive osteosynthesis staples2014-12-23

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