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510(k) K171018

Axis Charcot Fixation System, 4.5 to 8.5mm Screw System by Extremity Medical, LLC — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2017
Date Received
April 5, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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