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510(k) K220147

Aspiron S ACP System by U&I Corporation — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2022
Date Received
January 19, 2022
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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