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510(k) K131454

KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD by Total Joint Orthopedics, Inc. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2014
Date Received
May 20, 2013
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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  • K190280 — Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - (March 15, 2019)
  • K180929 — Klassic HD® Hip System (May 9, 2018)
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  • 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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