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    FDA 510(K) K210497, SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine ...

    FDA 510(K) K210497, SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine ...

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    Device Classification Name    Intervertebral Fusion Device With Bone Graft, Lumbar
    510(k) Number    K210497
    Device Name    SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System
    Applicant    SeaSpine Orthopedics Corporation
    Regulation Number    888.3080
    Classification Product Code    MAX  
    Subsequent Product Codes    MQP      ODP      OVD      OVE  
    Date Received    02/22/2021
    Decision Date    07/07/2021
    Decision    Substantially Equivalent (SESE)
    Regulation Medical Specialty    Orthopedic

    Total pages: 498  
    Fully redacted pages: 259  
    Content pages: 239  

    PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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