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510(k) K170342

Ocata Anterior Cervical System by Kalitec Direct, LLC — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2017
Date Received
February 3, 2017
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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