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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, fixation, spinal intervertebral body
510(k) Number K212139
Device Name Admiral ACP System
Applicant
SeaSpine Orthopedics Corporation
5770 Armada Drive
Carlsbad,  CA  92008
Applicant Contact Cindy Fong
Correspondent
SeaSpine Orthopedics Corporation
5770 Armada Drive
Carlsbad,  CA  92008
Correspondent Contact Cindy Fong
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received07/08/2021
Decision Date 09/01/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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