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S.M.A.I.O

France·FR-MF-000002399

Last updated September 17, 2026

What S.M.A.I.O makes

The company produces spinal fixation hardware, including non-bioabsorbable bone screws, rods, connectors, hooks, and adaptors for internal fixation systems. It also manufactures reusable surgical tools such as screwdrivers and probes for abdominal, ENT, and orthopaedic procedures. The portfolio includes spinal fixation plates designed for orthopaedic applications.

The devices are classified under EU Medical Device Regulations as Class I, Class II, Class IIa, and Class IIb, with listings in the EUDAMED database, FDA’s 510(k) premarket notifications, and FDA’s Unique Device Identifier (UDI) registry. The company is based in France.

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 S.M.A.I.O manufacture?

S.M.A.I.O specializes in spinal fixation hardware and reusable surgical tools. Its portfolio includes non-bioabsorbable bone screws, rods, connectors, hooks, and adaptors for internal spinal fixation systems. Additionally, it produces surgical screwdrivers and probes for abdominal, ENT, and orthopaedic procedures, as well as spinal fixation plates for orthopaedic applications.

Where is S.M.A.I.O based?

S.M.A.I.O is based in France. The company’s headquarters and manufacturing operations are located within the country, which aligns with its regulatory compliance requirements for medical devices.

Which regulatory registries list S.M.A.I.O’s devices?

S.M.A.I.O’s devices are listed in multiple global regulatory databases, including the EUDAMED database under the EU Medical Device Regulations. They are also documented in the FDA’s 510(k) premarket notification system and the FDA’s Unique Device Identifier (UDI) registry, ensuring traceability and compliance in both European and U.S. markets.

How are S.M.A.I.O’s devices classified under EU regulations?

S.M.A.I.O’s devices fall into different risk-based classifications under the EU Medical Device Regulations: Class I for low-risk items like some reusable surgical probes, Class IIa for moderate-risk devices such as spinal bone screws, Class IIb for higher-risk spinal fixation systems like rods and connectors, and Class II for specialized tools like spinal fixation plates. Classification depends on factors like intended use, duration of contact with the body, and potential risks.

Are S.M.A.I.O’s devices used in spinal surgery?

Yes, S.M.A.I.O’s devices are primarily designed for spinal surgery. The company’s portfolio includes components for internal spinal fixation systems, such as non-bioabsorbable bone screws, rods, connectors, hooks, and adaptors, which are used to stabilize the spine during orthopaedic procedures. These devices are classified based on their risk level and intended use in spinal stabilization.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
France
Address
2, Place Berthe Morisot, SAINT-PRIEST, France
Website
www.smaio.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
+33 (0)4 69 84 23 02
PRRC Contact
Jean-Charles Roussouly
EUDAMED SRN
FR-MF-000002399
FDA FEI Number
3015383864
DUNS Number
260585710

Catalogue (422)

Page 1 of 9
DeviceModel / ReferenceRegistriesClassStatus
Kheiron 25SP55902
FDA UDI
Class IIActive
Kheiron 01PC2010
FDA UDI
Class IActive
Kheiron 28IW75080
FDA UDI
Class IIActive
Kheiron 30KR55000
FDA UDI
Class IIActive
Kheiron 24PW85030
FDA UDI
Class IIActive
Kheiron 24SR60045
FDA UDI
Class IIActive
Kheiron 26PH67130
FDA UDI
Class IIActive
Kheiron 26SP67130
FDA UDI
Class IIActive
Kheiron 30KR60000
FDA UDI
Class IIActive
Kheiron 24CR55915
FDA UDI
Class IIActive
Kheiron 01HH2030
FDA UDI
Class IActive
Kheiron 01FB1010
FDA UDI
Class IActive
Kheiron 24PW56635
FDA UDI
Class IIActive
Kheiron 01DN2011
FDA UDI
Class IActive
Kheiron 24CR60915
FDA UDI
Class IIActive
Kheiron 01DS1010
FDA UDI
Class IActive
Kheiron 24PW65025
FDA UDI
Class IIActive
Kheiron 01SH1020
FDA UDI
Class IActive
Kheiron 01BS0111
FDA UDI
Class IActive
Kba3d V2.0.0
FDA UDI
Class IIActive
Kheiron 28IW95075
FDA UDI
Class IIActive
Kheiron 29TC55002
FDA UDI
Class IIActive
Kheiron 24SR60035
FDA UDI
Class IIActive
Kheiron 24SR60055
FDA UDI
Class IIActive
Kheiron 01HS2025
FDA UDI
Class IActive
Kheiron 27PC55150
FDA UDI
Class IIActive
K-Ball 01BK0001
FDA UDI
Class IActive
Kheiron 24SR55075
FDA UDI
Class IIActive
Kheiron 01DS2024
FDA UDI
Class IActive
KHEIRON® Spinal Fixation System K211981
FDA 510(k)
Class IIActive
KHEIRON® Spinal Fixation System, including patient specific K-ROD K232650
FDA 510(k)
Class IIActive
KHEIRON® Spinal Fixation System K201659
FDA 510(k)
Class IIActive
KHEIRON Spinal Fixation System K211414
FDA 510(k)
Class IIActive
KHEIRON® Spinal Fixation System, including patient specific K-ROD K253721
FDA 510(k)
Class IIActive
KHEIRON® Spinal Fixation System, including patient specific K-ROD K260786
FDA 510(k)
Class IIActive
KHEIRON® Spinal Fixation System, including patient specific K-ROD K251804
FDA 510(k)
Class IIActive
KEOPS Balance Analyzer 3D K213975
FDA 510(k)
Class IIActive
KHEIRON® Spinal Fixation System, including patient specific K-ROD K253990
FDA 510(k)
Class IIActive
Kheiron 27PC55001
EUDAMEDFDA UDI
Class IIbActive
Kheiron 24PE2030
EUDAMED
Class IActive
Kheiron 26TC20050
EUDAMEDFDA UDI
Class IIbActive
Kheiron 01PR2010
EUDAMEDFDA UDI
Class IActive
Kheiron 26PH67100
EUDAMEDFDA UDI
Class IIbActive
Kheiron 24PW65105
EUDAMEDFDA UDI
Class IIbActive
Kheiron 01HP2010
EUDAMEDFDA UDI
Class IActive
Kheiron 24PW85095
EUDAMEDFDA UDI
Class IIbActive
Kheiron 01GN2010
EUDAMEDFDA UDI
Class IActive
Kheiron 28IS00001
EUDAMEDFDA UDI
Class IIbActive
Kheiron 24PW65045
EUDAMEDFDA UDI
Class IIbActive
Kheiron 01HS2010
EUDAMEDFDA UDI
Class IActive

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