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510(k) K230546

SIGNEX by Osteonic Co., Ltd. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2024
Date Received
February 28, 2023
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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  • K243467 — Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) (December 3, 2024)
  • K233659 — Suture Wing (December 26, 2023)
  • K231322 — Fix2Lock(PEEK Self Punching) (June 7, 2023)
  • K231326 — Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) (May 31, 2023)
  • K210360 — Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neu (January 27, 2022)
  • K211992 — Ortho MI System (October 15, 2021)
  • K210122 — Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) (August 27, 2021)

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  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
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  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
  • K251732 — Wrist Fracture System (February 12, 2026)
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