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510(k) K161520

ELEOS Limb Salvage System by Onkos Surgical, Inc. — Product Code KRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2016
Date Received
June 2, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3510
Review Panel
OR
Submission Type

Other clearances by Onkos Surgical, Inc.

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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)
  • K203090 — ELEOS Limb Salvage System featuring BIOGRIP (December 11, 2020)
  • K180130 — ELEOS™ Bipolar Acetabular System (February 23, 2018)

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