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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K252546
Device Name VantageTM Lumbar Decompression Kit
Applicant
Allevion Medical, LLC
915 Clint Moore Rd.
Boca Raton,  FL  33487
Applicant Contact Stephen Inglese
Correspondent
Allevion Medical, LLC
915 Clint Moore Rd.
Boca Raton,  FL  33487
Correspondent Contact Stephen Inglese
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
HAE  
Date Received08/12/2025
Decision Date 03/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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