FDA 510(k), K072221, MODIFICATION TO TRIATHLON TS KNEE SYSTEM

FDA 510(k), K072221, MODIFICATION TO TRIATHLON TS KNEE SYSTEM

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510(K) Number: K072221
Device Name: MODIFICATION TO TRIATHLON TS KNEE SYSTEM
Manufacturer: HOWMEDICA OSTEONICS CORP.
Device Classification Name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
Regulation Number: 888.3560
Classification Product Code: JWH
Date Received: 08/10/2007
Decision Date: 10/15/2007
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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