FDA 510(k) Application Details - K223303

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K223303
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant Axon Spine Medical System
Via Lepanto 84
Pompei 80045 IT
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Contact Salvatore Accardo
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 10/27/2022
Decision Date 08/30/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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