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510(k) K172906

REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement by Osteoremedies, LLC — Product Code KWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2018
Date Received
September 22, 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

Other clearances by Osteoremedies, LLC

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  • K231556 — SPECTRUM® GV Bone Cement (December 20, 2023)
  • K223650 — REMEDY Stemmed Knee Spacer (January 5, 2023)
  • K192995 — OsteoRemedies Hip Spacer System (January 10, 2020)
  • K191981 — REMEDY Acetabular Cup (August 23, 2019)
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  • K173967 — Remedy Acetabular Cup (February 22, 2018)
  • K152267 — Remedy® Shoulder Spacer (December 15, 2015)

Other clearances for product code KWL

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  • K242865 — Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer (June 12, 2025)
  • 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)
  • K173967 — Remedy Acetabular Cup (February 22, 2018)
  • K143184 — Evolve UniPolar Head (March 17, 2015)
  • K112470 — 2GC HIP/KNEE MODULAR SPACER (April 5, 2012)