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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, Lumbar
510(k) Number K240126
Device Name ProAM ALIF System
Applicant
Pro Surgical, Inc.
3875 Copper Crest Rd.
Encinitas,  CA  92024
Applicant Contact Blain Jason
Correspondent
Pro Surgical, Inc.
3875 Copper Crest Rd.
Encinitas,  CA  92024
Correspondent Contact Jason Blain
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Code
MAX  
Date Received01/16/2024
Decision Date 05/03/2024
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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