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510(k) K210792

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2021
Date Received
March 15, 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

Other clearances by Auxein Medical Private Limited

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  • K213110 — AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw- (December 16, 2022)
  • 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)
  • K203029 — Auxilock Titanium Interference Screw (August 20, 2021)

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