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510(k) K211324

2.4mm Distal Radius System by Auxein Medical Private Limited — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2022
Date Received
April 30, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K213104 — Auxilock Titanium Screw-In Suture Anchor (July 29, 2022)
  • K210792 — Auxein Nailing System (August 25, 2021)
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