Home / 510(k) Clearances / K211712

510(k) K211712

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 by Orthofix US, LLC — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2022
Date Received
June 3, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

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