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510(k) K170344

Tahoe Uni Knee System by Consensus Orthopedics, Inc. — Product Code HSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2017
Date Received
February 3, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3520
Review Panel
OR
Submission Type

Other clearances by Consensus Orthopedics, Inc.

  • K163167 — CKS Plus Knee System (August 9, 2017)
  • K160515 — PS2 Knee System (December 19, 2016)
  • 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)
  • K121263 — TAPER SET HIP SYSTEM RDP STEM (May 22, 2012)

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