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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, Lumbar
510(k) Number K253894
Device Name BMD Titanium Spinal Fusion System
Applicant
Global Biomedica s.r.o.
Jablunkovská 855/48
Ceský Tešín,  CZ 737 01
Applicant Contact Piotr Koziel
Correspondent
BioVera, Inc.
65 Promenade Saint Louis
Notre-Dame-De-L’Ile-Perrot,  CA J7W3J6
Correspondent Contact Robert Poggie
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
ODP  
Date Received12/04/2025
Decision Date 05/28/2026
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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