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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, Cervical
510(k) Number K200549
Device Name Lucero Medical Cervical Cage System
Applicant
Lucero Medical, LLC
6815 W. St.Sboro
Richfield,  OH  44286
Applicant Contact Lee Strnad
Correspondent
Backroads Consulting, Inc.
12520 Heath Rd.
Chesterland,  OH  44026
Correspondent Contact Karen E. Warden
Regulation Number888.3080
Classification Product Code
ODP  
Date Received03/03/2020
Decision Date 12/16/2020
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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