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NOVASTEP

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
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
+33299338650
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
264255288

Catalogue (757)

Page 4 of 16
DeviceModel / ReferenceRegistriesClassStatus
centrolock® XTI06026
FDA UDI
Class IIActive
Nexis HS020020
FDA UDI
Class IIUnknown
airlock® PL020100
FDA UDI
Class IIActive
nexis® SC060036
FDA UDI
Class IIActive
Lync XTR00020
FDA UDI
Class IIActive
nexis® XRE01008D
FDA UDI
Class IActive
nexis® XRE01007D
FDA UDI
Class IActive
Arcad SUI08003
FDA UDI
Class IUnknown
airlock® XTI02015
FDA UDI
Class IIActive
airlock® XTI04123
FDA UDI
Class IIActive
airlock® XTI03011
FDA UDI
Class IIActive
Nexis HS020032
FDA UDI
Class IIUnknown
nexis® XDB01009D
FDA UDI
Class IActive
Peca® XGA01009
FDA UDI
Class IActive
Peca® 3 XSD02003
FDA UDI
Class IActive
airlock® SP013516
FDA UDI
Class IIActive
Arcad SUI08006
FDA UDI
Class IUnknown
eXpress® 139-00-0020
FDA UDI
Class IActive
eXpress® 139-00-0225
FDA UDI
Class IActive
arcad® CS062020
FDA UDI
Class IIActive
Airlock® Utility ACC1006P0010
FDA UDI
Class IActive
nexis® SC050050
FDA UDI
Class IIActive
airlock® PL040034
FDA UDI
Class IIActive
airlock® SP013012
FDA UDI
Class IIActive
Airlock® XMS01005
FDA UDI
Class IActive
Nexis XTR00009
FDA UDI
Class IIUnknown
eXpress® 139-00-0125
FDA UDI
Class IActive
nexis® Ø5/Ø7 XGA01007
FDA UDI
Class IActive
centrolock® SP012510
FDA UDI
Class IIActive
Peca® XMS01038-4
FDA UDI
Class IActive
arcad® 2.0 SUI09001
FDA UDI
Class IActive
centrolock® SP012520
FDA UDI
Class IIActive
Peca® XMS01038-3
FDA UDI
Class IActive
airlock® PL030402
FDA UDI
Class IIActive
Airlock® XDB01006
FDA UDI
Class IUnknown
Peca® 2.0 PS060034
FDA UDI
Class IIActive
Nexis® MIS XRE01024
FDA UDI
Class IActive
Nexis HS020016
FDA UDI
Class IIUnknown
Peca® 2.0 XMS01038-8
FDA UDI
Class IActive
nexis® SC060090
FDA UDI
Class IIActive
Peca® PS050128
FDA UDI
Class IIActive
nexis® Ø7 XDG01016
FDA UDI
Class IActive
Peca® PS020024
FDA UDI
Class IIActive
airlock® SP023530
FDA UDI
Class IIActive
arcad® 25 XDG01006
FDA UDI
Class IActive
airlock® SP013010
FDA UDI
Class IIActive
lync® XDB01003
FDA UDI
Class IActive
airlock® SP023018
FDA UDI
Class IIActive
nexis® Ø5 XSD05002
FDA UDI
Class IActive
airlock® SP013026
FDA UDI
Class IIActive

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