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FDA 510(k) Applications Submitted by Orthofix US LLC
FDA 510(k) Number
Submission Date
Device Name
Applicant
K211712
06/03/2021
3░ Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System
Orthofix US LLC
K213951
12/17/2021
FORZA XP Expandable Spacer System
Orthofix US LLC
K230252
01/30/2023
OFIX MIS App
Orthofix US LLC
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