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510(k) K173967

Remedy Acetabular Cup by Osteoremedies, LLC — Product Code KWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2018
Date Received
December 29, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

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  • K234028 — COPAL® exchange G hip spacer; COPAL® G+V (February 15, 2024)
  • K222632 — UHR Bipolar Implants, Restoration GAP II Implants (October 21, 2022)
  • K192995 — OsteoRemedies Hip Spacer System (January 10, 2020)
  • K191981 — REMEDY Acetabular Cup (August 23, 2019)
  • K172906 — REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement (August 29, 2018)
  • K143184 — Evolve UniPolar Head (March 17, 2015)
  • K112470 — 2GC HIP/KNEE MODULAR SPACER (April 5, 2012)