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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 K220696
Device Name uCerv Flux-C 3D Porous Titanium Cervical Interbody
Applicant
Ulrich Medical USA
18221 Edison Ave.
Chesterfield,  MO  63005
Applicant Contact Hans Stover
Correspondent
Ulrich Medical USA
18221 Edison Ave.
Chesterfield,  MO  63005
Correspondent Contact Hans Stover
Regulation Number888.3080
Classification Product Code
ODP  
Date Received03/09/2022
Decision Date 08/19/2022
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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