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510(k) K180130

ELEOS™ Bipolar Acetabular System by Onkos Surgical, Inc. — Product Code KWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2018
Date Received
January 17, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device Class
Class II
Regulation Number
888.3390
Review Panel
OR
Submission Type

Other clearances by Onkos Surgical, Inc.

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  • 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)
  • K161520 — ELEOS Limb Salvage System (October 28, 2016)

Other clearances for product code KWY

  • K243634 — Maxx Libertas Bipolar Hip Head (Bipolar Hip) (August 25, 2025)
  • K231526 — CORAIL Cemented Femoral Stem (December 19, 2023)
  • K223441 — SpaceFlex Acetabular Cup (March 23, 2023)
  • K221794 — Vario-Cup System (July 20, 2022)
  • K220492 — COPAL exchange G hip spacer (March 23, 2022)
  • K200709 — Kyocera Bipolar Hip System (April 17, 2020)
  • K192236 — Fitmore Hip Stem (November 5, 2019)
  • K191016 — COPAL exchange G Hip and Knee Spacers (November 1, 2019)
  • K191297 — iNSitu Bipolar Hip System (September 17, 2019)
  • K191569 — Implantcast ic-Bipolar Head System (August 28, 2019)