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510(k) K253046

HERA Interlocking Intramedullary Nailing System by ZheJiang Decans Medical Devices Co., Ltd. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2026
Date Received
September 22, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

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  • K253213 — SAGI Cervical Cage System (April 20, 2026)
  • K252774 — Uni-C Cervical Cage System (April 15, 2026)
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  • K242195 — Gemini Cervical Fusion Cage System (November 4, 2024)
  • K242267 — Gemini Medical Cage System (October 8, 2024)

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