FDA 510(k), K042993, TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT

FDA 510(k), K042993, TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT

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510(K) Number: K042993
Device Name: TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT
Manufacturer: DENISE DUCHENE
Device Classification Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Regulation Number: JWH
Classification Product Code: KXA
Date Received: 11/01/2004
Decision Date: 01/12/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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