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510(k) K243608

TRIGEN Stable Lock Nut & Washer by Smith & Nephew, Inc. — Product Code JDS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2025
Date Received
November 22, 2024
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

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Other clearances for product code JDS

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  • K233150 — NET BRAND Osteosynthesis Nailing System (February 20, 2024)
  • K230761 — TRIGEN META-NAIL Nail System (June 14, 2023)
  • K201336 — DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails (September 3, 2020)
  • K192003 — Auxein Nailing System (June 10, 2020)
  • K193533 — WIN Flexible Nail System (February 20, 2020)
  • K141737 — CONVENTUS PHS SYSTEM (April 8, 2015)
  • K123948 — CHINA NAILS AND ACCESSORIES (March 14, 2013)
  • K111667 — SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS (December 5, 2011)