FDA 510(k) Application Details - K240090

Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue

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510(K) Number K240090
Device Name Fastener, Fixation, Biodegradable, Soft Tissue
Applicant CONMED Corporation
525 French Road
Utica, NY 13502 US
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Contact Dionne Sanders
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Regulation Number 888.3030

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Classification Product Code MAI
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Date Received 01/12/2024
Decision Date 03/05/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K240090


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