FDA 510(k) Application Details - K231769

Device Classification Name

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510(K) Number K231769
Device Name activL« Next Generation Instrumentation
Applicant Aesculap Implants Systems LLC
3773 Corporate Parkway
Center Valley, PA 18034 US
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Contact Hamza Ahmed
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Regulation Number

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Classification Product Code QLQ
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Date Received 06/16/2023
Decision Date 07/13/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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