ARTHREX, INC.

Entity profile compiled from public source records

Public Record Profile Registrations: 20 510(k) filings: 1 Recalls: 0

Known Identifiers & Locations

FEI Numbers 1220246, 3002579136, 3006990600, 3007193505, 3009423112, 3010331645, 3011230048, 3012470322, 3013700547, 3014004349, 3014262693, 3015231789, 3015974593, 3016851379, 3019269298, 3020704423, 3021226419, 3027339877, 3030926959, 3031238646
Owner Operator Numbers 1220287
Locations Covered Auckland, NZ; Ave Maria, FL, US; Bogota Cundinamarca, CO; Col. Napoles Mexico, MX; Fort Myers, FL, US; Frenchs Forest New South Wales, AU; Gangnam-gu Seoul, KR; London Ontario, CA; Munich Bavaria, DE; Naples, FL, US; Odelzhausen Bavaria, DE; Pendleton, SC, US; Pudahuel Region Metropolitana, CL; Santa Barbara, CA, US; Sao Paulo, BR; Shanghai, CN; Shinjuku-ku Tokyo, JP; Singapore Central Singapore, SG; Venlo Limburg, NL

Registered Establishments (20)

Registration # Establishment Name Location Establishment Type(s) Action
1220246 ARTHREX, INC. Naples, FL, US Develop Specifications But Do Not Manufacture At This Facility View Details
3002579136 Arthrex GmbH Munich Bavaria, DE Export Device to the United States But Perform No Other Operation on Device View Details
3006990600 Arthrex California Technology, Incorporated Santa Barbara, CA, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3007193505 ARTHREX GMBH Odelzhausen Bavaria, DE Export Device to the United States But Perform No Other Operation on Device View Details
3009423112 Arthrex Logistic Center Fort Myers, FL, US Manufacture Medical Device View Details
3010331645 Arthrex, Inc. Ave Maria, FL, US Manufacture Medical Device for Another Party (Contract Manufacturer),Sterilize Medical Device for Another Party (Contract Sterilizer) View Details
3011230048 Arthrex Mexico, S.A. de C.V. Col. Napoles Mexico, MX Export Device to the United States But Perform No Other Operation on Device View Details
3012470322 Arthrex Japan G.K. (Shinjuku) Shinjuku-ku Tokyo, JP Export Device to the United States But Perform No Other Operation on Device View Details
3013700547 Arthrex Korea Ltd. Gangnam-gu Seoul, KR Export Device to the United States But Perform No Other Operation on Device View Details
3014004349 Arthrex Singapore Pte Ltd. Singapore Central Singapore, SG Export Device to the United States But Perform No Other Operation on Device View Details
3014262693 Arthrex (Shanghai) Co., Ltd. Shanghai, CN Export Device to the United States But Perform No Other Operation on Device View Details
3015231789 Arthrex Manufacturing Inc. Pendleton, SC, US Manufacture Medical Device View Details
3015974593 Arthrex do Brazil Importacao e Comercio de Equipamentos Medicos Ltda Sao Paulo, BR Export Device to the United States But Perform No Other Operation on Device View Details
3016851379 Arthrex Distribution Hub EMEA B.V. Venlo Limburg, NL Export Device to the United States But Perform No Other Operation on Device View Details
3019269298 Arthrex Australia Pty Ltd. Frenchs Forest New South Wales, AU Export Device to the United States But Perform No Other Operation on Device View Details
3020704423 Arthrex New Zealand Limited Auckland, NZ Export Device to the United States But Perform No Other Operation on Device View Details
3021226419 Arthrex Colombia SAS Bogota Cundinamarca, CO Export Device to the United States But Perform No Other Operation on Device View Details
3027339877 Arthrex Chile SPA Pudahuel Region Metropolitana, CL Export Device to the United States But Perform No Other Operation on Device View Details
3030926959 Arthrex Logistic Center Canada London Ontario, CA Export Device to the United States But Perform No Other Operation on Device View Details
3031238646 Arthrex Medical Device (Shanghai) Co. Ltd. Shanghai, CN Export Device to the United States But Perform No Other Operation on Device View Details

510(k) Premarket Notifications (1)

Submission # Device Name Decision Date Decision Description Action
K130510 ARTHREX COMPRESSION PLATES 2013-09-25 Substantially Equivalent View Details

FDA Recall History (0)

No recall records found for this entity.

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