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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Cement, Posterior Screw Augmentation
510(k) Number K221926
Device Name Invictus® Bone Cement, Invictus Spinal Fixation System
Applicant
Alphatec Spine, Inc.
1950 Camino Vide Roble
Carlsbad,  CA  92008
Applicant Contact Aditya Aiyer
Correspondent
Alphatec Spine, Inc.
1950 Camino Vide Roble
Carlsbad,  CA  92008
Correspondent Contact Aditya Aiyer
Regulation Number888.3027
Classification Product Code
PML  
Subsequent Product Codes
KWP   KWQ   NKB  
Date Received07/01/2022
Decision Date 12/20/2022
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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