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    <manufacturerName>K2M, Inc.</manufacturerName>
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    <lastUpdated>2026-08-04T18:10:04.968Z</lastUpdated>
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    <deviceName>AN Lordotic Oblique Trials-Cascadia Interbody System</deviceName>
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    <tradeName>CASCADIA™ Interbody System</tradeName>
    <deviceName>Cascadia: Inserter</deviceName>
    <manufacturerName>K2M, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000004440</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnCode>L091001</emdnCode>
    <emdnDescription>INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6101-90170</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-04T18:09:58.577Z</lastUpdated>
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    <tradeName>CASCADIA™ Interbody System</tradeName>
    <deviceName>Cascadia: Pusher</deviceName>
    <manufacturerName>K2M, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000004440</manufacturerSrn>
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    <reference>6101-90168</reference>
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    <tradeName>ALEUTIAN® Interbody Systems</tradeName>
    <deviceName>Aleutian - PLIF Osteotome</deviceName>
    <manufacturerName>K2M, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000004440</manufacturerSrn>
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    <reference>602-90508</reference>
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    <tradeName>ALEUTIAN® Interbody Systems</tradeName>
    <deviceName>Aleutian: Cup</deviceName>
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    <manufacturerSrn>US-MF-000004440</manufacturerSrn>
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    <reference>602-90506</reference>
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    <lastUpdated>2026-08-04T18:09:53.755Z</lastUpdated>
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    <tradeName>ALEUTIAN® Interbody Systems</tradeName>
    <deviceName>Aleutian: Convex Trial</deviceName>
    <manufacturerName>K2M, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000004440</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>602-90243</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-04T18:09:52.154Z</lastUpdated>
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    <udiDi>10888857114173</udiDi>
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    <tradeName>ALEUTIAN® Interbody Systems</tradeName>
    <deviceName>Aleutian: Curette Connector Shaft</deviceName>
    <manufacturerName>K2M, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000004440</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>ORTHOPAEDIC SURGERY SPOONS AND CURETTES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>602-90010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-04T18:09:51.354Z</lastUpdated>
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    <tradeName>ALEUTIAN® Interbody Systems</tradeName>
    <deviceName>Aleutian: Implant Removal Tool</deviceName>
    <manufacturerName>K2M, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000004440</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>5303-90005</reference>
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    <lastUpdated>2026-08-04T18:09:49.840Z</lastUpdated>
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    <tradeName>ALEUTIAN® Interbody Systems</tradeName>
    <deviceName>Aleutian: Bone Funnel Pusher</deviceName>
    <manufacturerName>K2M, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000004440</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>3303-90160</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-04T18:09:47.361Z</lastUpdated>
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    <tradeName>ALEUTIAN® Interbody Systems</tradeName>
    <deviceName>Aleutian: Nerve Root Retractor</deviceName>
    <manufacturerName>K2M, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000004440</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>3303-90158</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-04T18:09:45.745Z</lastUpdated>
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    <tradeName>ALEUTIAN® Interbody Systems</tradeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>3201-90310</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
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    <tradeName>ALEUTIAN® Interbody Systems</tradeName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>3201-90302</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
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