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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 K212358
Device Name Romero Cervical Cage
Applicant
Spineup, Inc.
100 N. Biscayne Blvd. Suite 3070
Miami,  FL  33132
Applicant Contact Philippe Laurito
Correspondent
Spineup, Inc.
100 N. Biscayne Blvd. Suite 3070
Miami,  FL  33132
Correspondent Contact Ryan Weitzel
Regulation Number888.3080
Classification Product Code
OVE  
Subsequent Product Code
ODP  
Date Received07/29/2021
Decision Date 01/10/2022
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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