Novastep
FranceFDA applicant, unverified FDA FEI 3010673777
Novastep is a medical device manufacturer, with 962 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I) as of 12 Nov 2026.
- Devices
- 962
- Registrations
- FDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 953
- EUDAMED 739
- FDA 510(k) 9
- Device classes
- FDA Class II 557
- FDA Class I 405
- Identifiers
- FDA FEI 3010673777
- DUNS 264255288
At a glance
Market reach
- United States
- FDA FEI
What Novastep makes
NovaStep manufactures reusable orthopaedic surgical instruments and fixation hardware, including non-sliding bone screws, internal fixation system kits, reusable surgical templates, and non-bioabsorbable fixation plates. Their portfolio also includes cannulated drill bits, sterilization/disinfection containers, non-cutting staple loading units, and reusable screwdrivers. These products are designed for orthopaedic procedures requiring precise bone alignment and stabilization.
NovaStep’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable regulatory standards for medical device authorisation.
Catalogue
Search and filter all 962 devicesShowing 1-50 of 962
Company details
- FDA FEI number
- 3010673777
- DUNS number
- 264255288
- Address
- 2 allee Jacques Frimot, RENNES Bretagne
- Phone
- +33299338650
Frequently asked questions
How many devices does NOVASTEP have in the registry?
The registry currently lists 962 devices for NOVASTEP. Devices recorded under merged duplicate company entries are counted once.
Which registries list NOVASTEP's devices?
Among its 50 most recently registered devices, NOVASTEP has devices listed in EUDAMED (50 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do NOVASTEP's devices fall under?
Among its 50 most recently registered devices, the classes recorded for NOVASTEP's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from NOVASTEP in the registry?
The most recently registered devices listed for NOVASTEP include airlock® SP014014, airlock® SP014016, airlock® SP014018 and airlock® SP014022.