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510(k) K203090

ELEOS Limb Salvage System featuring BIOGRIP by Onkos Surgical — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2020
Date Received
October 13, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type

Other clearances by Onkos Surgical

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  • DEN210058 — ELEOSx™ Limb Salvage System (April 5, 2024)
  • K223348 — My3D® Personalized Pelvic Reconstruction (January 30, 2023)
  • K212815 — My3D® Personalized Pelvic Reconstruction (July 6, 2022)
  • K211677 — ELEOS Limb Salvage System (July 28, 2021)
  • K203815 — ELEOS Limb Salvage System with BioGrip (June 9, 2021)
  • K203588 — ELEOS™ Limb Salvage System (February 5, 2021)
  • K180130 — ELEOS™ Bipolar Acetabular System (February 23, 2018)
  • K161520 — ELEOS Limb Salvage System (October 28, 2016)

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  • K240418 — Stryker Orthopaedics Hip Systems Labeling Update (April 12, 2024)
  • K233261 — Global Modular Replacement System (December 8, 2023)
  • K222056 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (January 26, 2023)
  • K220216 — C-Stem AMT LE Prosthesis (July 22, 2022)
  • K213701 — Exeter® X3® RimFit® Cup (February 1, 2022)
  • K213816 — MPO Hip Instruments (January 5, 2022)
  • K210842 — VerSys Cemented Revision/Calcar (December 10, 2021)