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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 K240749
Device Name PILLAR SA Ti Spacer System (82-XXX)
Applicant
Orthofix, Inc.
3451 Plano Pkwy.
Lewisville,  TX  75056
Applicant Contact Tony John
Correspondent
Orthofix, Inc.
3451 Plano Pkwy.
Lewisville,  TX  75056
Correspondent Contact Tony John
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
OVD  
Date Received03/19/2024
Decision Date 05/28/2024
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
Recalls CDRH Recalls
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