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510(k) K223348

My3D® Personalized Pelvic Reconstruction by Onkos Surgical, Inc. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2023
Date Received
November 2, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

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

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