FDA 510(k), K962137, GENESIS II CONSTRAINED SYSTEM

FDA 510(k), K962137, GENESIS II CONSTRAINED SYSTEM

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510(K) Number: K962137
Device Name: GENESIS II CONSTRAINED SYSTEM
Manufacturer: THOMAS L CRAIG
Device Classification Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Regulation Number: JWH
Classification Product Code: KXA
Date Received: 06/03/1996
Decision Date: 08/02/1996
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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