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510(k) K193497

Fixone Biocomposite Interference Screw by Aju Pharm Co., Ltd. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2021
Date Received
December 17, 2019
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

Other clearances by Aju Pharm Co., Ltd.

  • K233601 — Fixone Meniscal Repair (August 2, 2024)
  • K230892 — Fixone Biocomposite Anchor (June 9, 2023)
  • K222423 — Fixone All Suture Anchor (March 23, 2023)
  • K203523 — Fixone hybrid knotless anchor (December 25, 2021)
  • K192709 — Fixone All Suture Anchor (December 15, 2020)
  • K192484 — Fixone Biocomposite Anchor (March 11, 2020)
  • K192032 — Fixone Biocomposite Small Anchor (March 3, 2020)
  • K171299 — Fixone Biocomposite Anchor (August 24, 2017)
  • K162070 — JOINIX CANNULAR SYSTEM (March 16, 2017)

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