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510(k) K110542

CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD by Consensus Orthopedics, Inc. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2011
Date Received
February 24, 2011
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 Consensus Orthopedics, Inc.

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  • K143725 — Consensus Knee System Modular Tibial Baseplate (March 4, 2015)
  • K133919 — CONSENSUS VITALITE TIBIAL INSERT (July 14, 2014)
  • K141043 — CS2 MULTI-HOLE ACETABULAR SHELL (May 19, 2014)
  • K130652 — VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT (December 17, 2013)
  • K122512 — CS2 HIP SYSTEM (November 5, 2012)
  • K120595 — UNISYN PLUS HIP STEM (October 12, 2012)
  • K121935 — TAPERSET HIP SMALL STEMS (September 10, 2012)

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