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Medtronic Sofamor Danek USA, Incorporated

Active in EUDAMED

Registered as Medtronic Sofamor Danek USA, Inc. in EUDAMED

United Statesfrom SRN EUDAMED SRN US-MF-000023095

Devices
87
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate

What Medtronic Sofamor Danek USA, Incorporated makes

Medtronic Sofamor Danek USA, Incorporated manufactures orthopedic hardware for spinal fixation, including fenestrated screws with bone cement for vertebral augmentation and growth rod conversion kits for pediatric spinal deformity correction.

These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue87

Newest first, rows 1-50 of 87

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  • Cd Horizon® Ref 55751026535

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • Fas, Screw, Sterile Ref 55946206545

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Modulex Shank Ref 55902507545

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Ref 55751027540

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Ref 55751025540

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • Fas, Screw, Sterile Ref 55946205540

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Ref 55040026550

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Solera® Voyager™ Ref 55750045545

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Ref 55751026545

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Fas, Screw, Sterile Ref 55946206540

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Fas, Screw, Sterile Ref 55946204535

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Ref 55040026555

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Solera® Voyager™ Ref 55750047550

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Slap Plate Ref 2980003

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Cd Horizon® Ref 55040024540

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Ref 55751025535

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • Cd Horizon® Ref 55040026535

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Ref 55751026550

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • Cd Horizon® Ref 55040026540

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Ref 55751026540

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Solera® Voyager™ Ref 55750046535

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Solera® Voyager™ Ref 55750047545

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Fas, Screw, Sterile Ref 55946204530

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Fas, Screw, Sterile Ref 55946206535

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Ref 55751025550

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Ref 55040024545

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Ref 55751025545

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Ref 55040025555

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Ref 55040025535

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Ref 55040028550

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Solera® Voyager™ Ref 55750047535

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Ref 55040027555

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Modulex Shank Ref 55902507540

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Ref 55751024535

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Modulex Shank Ref 55902508545

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Modulex Shank Ref 55902508540

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Ref 55751024530

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Ref 55040026530

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Medtronic Reusable Accessories Ref RBT090003

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Cd Horizon® Solera® Voyager™ Ref 55750017560

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Solera® Voyager™ Ref 55750046550

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Modulex Shank Ref 55902508550

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Ref 55040027540

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Fas, Screw, Sterile Ref 55946205535

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Ref 55751025530

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • Medtronic Reusable Accessories Ref RBT090005

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Cd Horizon® Solera® Voyager™ Ref 55750045550

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cd Horizon® Ref 55751024540

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • Cd Horizon® Solera® Voyager™ Ref 55750045530

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Centerpiece™ Ref G9010000271

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

Rows 1-50 of 87

Showing 1-50 of 87

Company details

EUDAMED SRN
US-MF-000023095
EUDAMED status
Active
EUDAMED registered name
Medtronic Sofamor Danek USA, Inc.
Registered address
1800, Pyramid Place, TN 38132, Memphis, United States
PRRC contact
Alison Webster(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 7 Sep 2028

EUDAMED certificates (1)

TÜV SÜD Product Service GmbH 0123 1 certificate

  • G11 039040 0084 Active Supplemented

    Quality management system EU MDR

    Issued
    24 Jul 2026
    Expires
    7 Sep 2028
    Reason
    Add device or group

Frequently asked questions

How many devices does Medtronic Sofamor Danek USA, Incorporated have in the registry?

The registry currently lists 87 devices for Medtronic Sofamor Danek USA, Incorporated. Devices recorded under merged duplicate company entries are counted once.

Which registries list Medtronic Sofamor Danek USA, Incorporated's devices?

Among its 50 most recently registered devices, Medtronic Sofamor Danek USA, Incorporated has devices listed in EUDAMED (50 devices) and FDA GUDID (6 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Medtronic Sofamor Danek USA, Incorporated's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Medtronic Sofamor Danek USA, Incorporated's devices are Class I and Class IIb. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Medtronic Sofamor Danek USA, Incorporated?

EUDAMED lists 1 certificate for Medtronic Sofamor Danek USA, Incorporated (quality management system) under MDR. The most recent was issued on 24 Jul 2026.

What are the newest devices from Medtronic Sofamor Danek USA, Incorporated in the registry?

The most recently registered devices listed for Medtronic Sofamor Danek USA, Incorporated include CD HORIZON®, FAS, SCREW, STERILE, Modulex Shank and CD HORIZON® SOLERA® VOYAGER™.

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