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510(k) K192003

Auxein Nailing System by Auxein Medical Private Limited — Product Code JDS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2020
Date Received
July 26, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Auxein Medical Private Limited

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  • K213018 — Auxilock GFS Mini, GFS II Large, and GFS Ultimate (November 18, 2022)
  • K213108 — Humerus & Ulna System (November 4, 2022)
  • K213014 — Varixis Elbow System (October 3, 2022)
  • K213109 — Auxilock Draw Tight Suture-Based Anchor (August 22, 2022)
  • K213104 — Auxilock Titanium Screw-In Suture Anchor (July 29, 2022)
  • K211324 — 2.4mm Distal Radius System (March 14, 2022)
  • K210792 — Auxein Nailing System (August 25, 2021)

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