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510(k) K202959

PolyLock Plating System by Fusion Orthopedics, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2020
Date Received
September 30, 2020
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

Other clearances by Fusion Orthopedics, LLC

  • K242091 — Bolo Button System (December 23, 2024)
  • K211843 — PolyLock Plating System (March 4, 2022)
  • K210159 — IntraLock System (July 23, 2021)
  • K193377 — TopLock Anchor System (November 25, 2020)
  • K192323 — PolyLock Small Bone Plating System (November 18, 2019)
  • K190136 — Fusion Silastic System (October 21, 2019)
  • K182342 — IntraLock Lapidus System (May 21, 2019)
  • K182684 — HammerTechTM Fixation System (November 23, 2018)
  • K181815 — DynaBridge (October 15, 2018)
  • K170624 — TalarLift STS (August 11, 2017)

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  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
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