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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

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.

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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