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510(k) K160515

PS2 Knee System by Consensus Orthopedics, Inc. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2016
Date Received
February 24, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

Other clearances by Consensus Orthopedics, Inc.

  • K170344 — Tahoe Uni Knee System (October 5, 2017)
  • K163167 — CKS Plus Knee System (August 9, 2017)
  • 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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