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Spineway SA

Active in EUDAMED

Registered as Spineway in EUDAMED

Also registered as Spineway

Francefrom SRN EUDAMED SRN FR-MF-000015893

Devices
943
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 2 in force. 1 certificate has expired.

See certificates

Market reach

European Union
EUDAMED actor, 2 certificates

What Spineway SA makes

Spineway SA manufactures internal spinal fixation systems, including bone-screw assemblies, non-bioabsorbable spinal plates, and polymeric spinal fusion cages, both sterile and non-sterile. Their portfolio also includes reusable orthopaedic surgical procedure kits and spinal bone screws for surgical interventions. The company produces systems for anterior and posterior spinal stabilization, such as the Mont Blanc Evo, TWIN PEAKS, and Blue Mountain Cervical Plate System.

The company’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. Spineway SA is based in the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue943

Newest first, rows 1-50 of 943

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  • C1TP04

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • M1MB11

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • M13D05

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • C1OPN01

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • C1SCK01

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • M13D03

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • M1MB07

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • C1OPN03

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • C1MB02

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • C1STD01

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • M13D02

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • M1MB06

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • C1OPN02

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • M13D01

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • C1OPN04

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • M2MB08

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • M13D04

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • C13D01

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • M1STD02

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • C1MIS04

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Mont Blanc Evo Systems 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Twin Peaks 1

    Withdrawn Registry: GUDID Class:II

  • Twin Peaks 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ayers Rock Cervical interbody fusion system 2

    Withdrawn Registry: GUDID Class:II

  • Blue Mountain 1

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Twin Peaks 1

    Withdrawn Registry: GUDID Class:II

  • Mont Blanc MIS Spinal Systems 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Twin Peaks 1

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Ayers Rock Cervical interbody fusion system 2

    Withdrawn Registry: GUDID Class:II

  • Blue Mountain Cervical Plate System 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Mont Blanc Spinal Systems 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Mont Blanc Spinal Systems 1

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Twin Peaks 1

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Twin Peaks 1

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Mont Blanc 1

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Mont Blanc MIS Spinal Systems 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Twin Peaks 1

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Blue Mountain 2

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Mont Blanc MIS Spinal Systems 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Mont Blanc 3

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Mont Blanc Spinal Systems 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Twin Peaks 1

    Withdrawn Registry: GUDID Class:II

  • Mont Blanc Spinal Systems 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Blue Mountain 1

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Twin Peaks 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Mont Blanc Evo Systems 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Mont Blanc Spinal Systems 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Mont Blanc MIS Spinal Systems 1

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Mont Blanc Spinal Systems 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Mont Blanc Spinal Systems 1

    Active Regimes: 510(k) Registry: GUDID Class:II

Rows 1-50 of 943

Showing 1-50 of 943

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
FR-MF-000015893
EU VAT number
FR96484163985
EUDAMED status
Active
EUDAMED registered name
Spineway
Registered address
7, Allée du moulin berger, 69130, Ecully, France
Phone
+33 4 72 77 01 52
PRRC contact
Sabina AHADDAD(public in EUDAMED)

EUDAMED certificates2

2 certificates1 valid, 1 expiredMDR 2next expiry 18 Oct 2031

EUDAMED certificates (2)

GMED SAS 0459 2 certificates

  • 40461 Active Supplemented

    Quality management system EU MDR

    Issued
    8 Sep 2026
    Expires
    18 Oct 2031
    Valid from
    19 Oct 2026
    Reason
    Other
  • 40461 Expired

    Quality management system EU MDR

    Issued
    24 Jul 2026
    Expires
    18 Oct 2026
    Reason
    Other

Frequently asked questions

How many devices does Spineway SA have in the registry?

The registry currently lists 943 devices for Spineway SA. Devices recorded under merged duplicate company entries are counted once.

Which registries list Spineway SA's devices?

Among its 50 most recently registered devices, Spineway SA has devices listed in EUDAMED (20 devices) and FDA GUDID (30 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Spineway SA's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Spineway SA's devices are Class I and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Spineway SA?

EUDAMED lists 2 certificates for Spineway SA (quality management system) under MDR. The most recent was issued on 8 Sep 2026.

What are the newest devices from Spineway SA in the registry?

The most recently registered devices listed for Spineway SA include C1TP04, M1MB11, M13D05 and C1OPN01.

Generated automatically from registry data and not verified by a human reviewer.