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510(k) K211261

Axis Charcot Fixation System by Extremity Medical, LLC — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2021
Date Received
April 26, 2021
Clearance Type
Special
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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