BEUDAMED
    3 results · 12ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Status: Terminated × Clear all

    ORCHESTRA/ORCHESTRA PLUS Programmer

    FDA Enforcement
    Class II ·Terminated·Sorin Group Italia S.r.l.·January 29, 2014

    REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.

    FDA Enforcement
    Class II ·Terminated·Materialise USA LLC·January 15, 2014

    ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.

    FDA Enforcement
    Class II ·Terminated·LDR Spine USA, Inc.·October 12, 2016