FDA 510(k) Application Details - K234056

Device Classification Name

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510(K) Number K234056
Device Name canturio« se (Canturio Smart Extension)
Applicant Canary Medical USA LLC
2710 Loker Ave. West, Suite 350
Carlsbad, CA 92010 US
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Contact Kevin Leung
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Regulation Number

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Classification Product Code QPP
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Date Received 12/22/2023
Decision Date 04/24/2024
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 K234056


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