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510(k) K151440

Klassic HD Hip System by Total Joint Orthopedics, Inc. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2015
Date Received
May 29, 2015
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

Other clearances by Total Joint Orthopedics, Inc.

  • K220483 — Platform® Acetabular System (September 23, 2022)
  • K211877 — Klassic Knee System (June 22, 2022)
  • K211602 — Klassic Knee System (July 23, 2021)
  • K202740 — Klassic Knee System Tibial Inserts, PS-Max (October 9, 2020)
  • K183596 — Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS (March 29, 2019)
  • K190280 — Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - (March 15, 2019)
  • K180929 — Klassic HD® Hip System (May 9, 2018)
  • K180159 — Klassic® Knee System (March 9, 2018)
  • K173104 — Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile (October 27, 2017)
  • K162422 — Klassic Knee System (October 28, 2016)

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