FDA 510(k), K042515, SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE

FDA 510(k), K042515, SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE

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510(K) Number: K042515
Device Name: SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE
Manufacturer: SMITH & NEPHEW, INC.
Device Classification Name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
Regulation Number: 888.3560
Classification Product Code: JWH
Date Received: 09/16/2004
Decision Date: 03/14/2005
Regulation Medical Specialty: Orthopedic
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