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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 9 of 16
DeviceModel / ReferenceRegistriesClassStatus
Peca® 2.0 PS070016
FDA UDI
Class IIActive
Nexis HS020022
FDA UDI
Class IIUnknown
eXpress® 139-25-2020-S
FDA UDI
Class IIActive
nexis® SC050048
FDA UDI
Class IIActive
Peca® PS050034
FDA UDI
Class IIActive
airlock® SP013008
FDA UDI
Class IIActive
Nexis HS010030
FDA UDI
Class IIUnknown
Airlock® XDB01005D
FDA UDI
Class IActive
arcad® CS041414
FDA UDI
Class IIActive
eXpress® 139-00-0210
FDA UDI
Class IActive
Airlock XMS01039-3
FDA UDI
Class IUnknown
airlock® SP013524
FDA UDI
Class IIActive
airlock® SP023026
FDA UDI
Class IIActive
airlock® XTI02024
FDA UDI
Class IIActive
Peca® PS050028
FDA UDI
Class IIActive
airlock® XTI02014
FDA UDI
Class IIActive
nexis® SC020024
FDA UDI
Class IIActive
Peca® 4 XRE01023
FDA UDI
Class IActive
Airlock SUI03001
FDA UDI
Class IIUnknown
Pecaplasty® CKW06002
FDA UDI
Class IActive
nexis® SC050034
FDA UDI
Class IIActive
arcad® 25 XFP03006
FDA UDI
Class IActive
eXpress® 139-00-0021
FDA UDI
Class IActive
Centrolock® XMS01040-2
FDA UDI
Class IActive
airlock® SP013510
FDA UDI
Class IIActive
nexis® SC060095
FDA UDI
Class IIActive
nexis® SC070095
FDA UDI
Class IIActive
airlock® SP013520
FDA UDI
Class IIActive
Centrolock® XRE01022D
FDA UDI
Class IActive
nexis® SUI01002
FDA UDI
Class IActive
Nexis TS020038
FDA UDI
Class IIUnknown
Nexis HS010016
FDA UDI
Class IIUnknown
airlock® SP013024
FDA UDI
Class IIActive
airlock® XTI05010
FDA UDI
Class IIActive
arcad® 10/static staples ACC1001P0003
FDA UDI
Class IActive
nexis® SC060070
EUDAMEDFDA UDI
Class IIActive
Nexis® MIS SC090030
FDA UDI
Class IIActive
centrolock® SP012524
EUDAMEDFDA UDI
Class IIActive
Nexis PS050040T
FDA UDI
Class IIUnknown
Airlock® XDB01021D
FDA UDI
Class IActive
nexis® SC070105
FDA UDI
Class IIActive
airlock® SP013020
FDA UDI
Class IIActive
arcad® CS041212
FDA UDI
Class IIActive
nexis® Ø5/Ø7 ACC1008P0001
FDA UDI
Class IActive
Nexis HS020014
FDA UDI
Class IIUnknown
airlock® PL010134
FDA UDI
Class IIActive
Peca® 3 XDB01017
FDA UDI
Class IActive
centrolock® SP032022
FDA UDI
Class IIActive
Nexis® MIS SC090020
FDA UDI
Class IIActive
Nexis HS010010
FDA UDI
Class IIUnknown

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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