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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Integrated Fixation, Cervical
510(k) Number K242517
Device Name ProAM ACDF System
Applicant
Pro Surgical, Inc.
1910 Palomar Point Way, Suite 201
Carlsbad,  CA  92008
Applicant Contact Jason Blain
Correspondent
Pro Surgical, Inc.
1910 Palomar Point Way, Suite 201
Carlsbad,  CA  92008
Correspondent Contact Jason Blain
Regulation Number888.3080
Classification Product Code
OVE  
Subsequent Product Code
ODP  
Date Received08/23/2024
Decision Date 11/20/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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