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Sign in to claim this brandNOVASTEP
US
Last updated May 24, 2026
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.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does NovaStep manufacture?
NovaStep specializes in reusable orthopaedic surgical instruments and fixation hardware. Their product range includes non-sliding bone screws, general internal orthopaedic fixation system implantation kits, reusable surgical templates, non-bioabsorbable fixation plates, cannulated surgical drill bits, sterilization/disinfection containers, non-cutting staple loading units, and reusable screwdrivers. These devices are designed to support orthopaedic procedures requiring precise bone alignment and stabilization.
Where is NovaStep based, and what regulatory standards do they follow?
NovaStep is based in the United States. While the company operates from there, its devices must comply with applicable U.S. regulatory requirements for medical device authorisation, such as those set by the FDA. The specific classification and regulatory pathway for each device depends on its risk level and intended use.
Which regulatory registries or databases list NovaStep’s devices?
NovaStep’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices by assigning a standardized identifier, ensuring transparency and traceability for regulatory and market surveillance purposes.
How are NovaStep’s devices classified under FDA regulations?
NovaStep’s devices fall under FDA’s Class I and Class II categories. The classification is determined by the risk associated with the device’s use and intended purpose. Class I devices generally pose the lowest risk, while Class II devices require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
What distinguishes NovaStep’s reusable orthopaedic instruments from single-use alternatives?
NovaStep’s reusable orthopaedic instruments are designed for repeated use after proper sterilization or disinfection, as indicated by their inclusion of items like sterilization/disinfection containers and reusable surgical templates or screwdrivers. Reusability can offer cost and environmental benefits compared to single-use alternatives, though the choice depends on clinical needs, infection control protocols, and regulatory compliance for reprocessing.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- novastep-ortho.com
- —
- —
- [email protected]
- Phone
- +33299338650
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 264255288
Catalogue (757)
Page 15 of 16| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| nexis® | SC070085 | FDA UDI | Class II | Active |
| nexis® | SC070110 | FDA UDI | Class II | Active |
| nexis®/PECA® | ACC1001P0019 | FDA UDI | Class I | Active |
| Express | 139-00-0001 | FDA UDI | Class I | Active |
| eXpress® | 139-00-0215 | FDA UDI | Class I | Active |
| arcad® | CS041416 | FDA UDI | Class II | Active |
| airlock® | SP013508 | FDA UDI | Class II | Active |
| airlock® | PL020103 | FDA UDI | Class II | Active |
| lync® | CM010030 | FDA UDI | Class II | Unknown |
| Centrolock® | XRE01014 | FDA UDI | Class I | Active |
| airlock® | SP013530 | FDA UDI | Class II | Active |
| Peca® 2.0 | PS060058 | FDA UDI | Class II | Active |
| Nexis | XTR10026 | FDA UDI | Class II | Unknown |
| Centrolock® | XMS01026 | FDA UDI | Class I | Active |
| Peca® 2.0 | XDB01029 | FDA UDI | Class I | Active |
| airlock® | XTI04022 | FDA UDI | Class II | Active |
| Nexis | TS020032 | FDA UDI | Class II | Unknown |
| Tarsoplasty® | SKW05005 | FDA UDI | Class I | Unknown |
| Peca® | PS050058 | FDA UDI | Class II | Active |
| Nexis® MIS | XGA01013 | FDA UDI | Class I | Active |
| nexis® Ø5 | XSD05001 | FDA UDI | Class I | Active |
| Airlock® | XGA01003 | FDA UDI | Class I | Active |
| Peca® | PS020042 | FDA UDI | Class II | Active |
| airlock® | XTI04117 | FDA UDI | Class II | Active |
| Airlock® | ACC1002P0008 | FDA UDI | Class I | Active |
| Peca® | PS050052 | FDA UDI | Class II | Active |
| Peca® | PS020018 | FDA UDI | Class II | Active |
| nexis® MIS | ACC1018P0001 | FDA UDI | Class I | Active |
| Peca® | PS050155 | FDA UDI | Class II | Active |
| Peca® 2.0 | XSD10002 | FDA UDI | Class I | Active |
| Peca® | PS050118 | FDA UDI | Class II | Active |
| Tarsoplasty® | SKW05006 | FDA UDI | Class I | Active |
| Peca® | CKW03002 | FDA UDI | Class I | Active |
| nexis® MIS | ACC1018P0002 | FDA UDI | Class I | Active |
| Peca® | ACC1001P0023 | FDA UDI | Class I | Active |
| Peca® 2.0 | XDG01036 | FDA UDI | Class I | Active |
| nexis® Ø5 | XMS01023 | FDA UDI | Class I | Active |
| Peca® | PS020046 | FDA UDI | Class II | Active |
| arcad® 15 | XDG01003 | FDA UDI | Class I | Active |
| Pecaplasty® | CKW06001 | FDA UDI | Class I | Unknown |
| arcad® 08 | XDG01002 | FDA UDI | Class I | Active |
| Tarsoplasty® | XMS01041-5 | FDA UDI | Class I | Active |
| nexis® Ø7 | XMS01022-4 | FDA UDI | Class I | Active |
| nexis® Ø5/Ø7 | ACC1008P0002 | FDA UDI | Class I | Active |
| Tarsoplasty® | XMS01041-4 | FDA UDI | Class I | Active |
| Peca® 2.0 | XSD10001 | FDA UDI | Class I | Active |
| Nexis® MIS | XSD02007 | FDA UDI | Class I | Active |
| Peca® | XMS01038-7 | FDA UDI | Class I | Active |
| Nexis osteosynthesis snap-off screws | K143146 | FDA 510(k) | Class II | Active |
| Nexis® compressive screws | K223468 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Novastep RENNES Bretagne · FR FEI 3010673777