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510(k) K190053

SECULOK™ ACP System by U&I Corporation — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2019
Date Received
January 11, 2019
Clearance Type
Special
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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