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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 Bone Graft, Lumbar
510(k) Number K220711
Device Name SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System
Applicant
SeaSpine Orthopedics Corporation
5770 Armada Dr.
Carlsbad,  CA  92008
Applicant Contact Kavita Chandrashekar
Correspondent
SeaSpine Orthopedics Corporation
5770 Armada Dr.
Carlsbad,  CA  92008
Correspondent Contact Jesse Albright
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Codes
KWQ   OVD  
Date Received03/11/2022
Decision Date 05/10/2022
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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