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510(k) K211843

PolyLock Plating System by Fusion Orthopedics — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2022
Date Received
June 15, 2021
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

  • K242091 — Bolo Button System (December 23, 2024)
  • K210159 — IntraLock System (July 23, 2021)
  • K193377 — TopLock Anchor System (November 25, 2020)
  • K202959 — PolyLock Plating System (November 24, 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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  • K254054 — VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (March 2, 2026)
  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
  • K252166 — RIB LINK™ Fixation System (February 26, 2026)
  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
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