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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K081458
Device Name PROVEN STEM EXTENDER
Applicant
Stelkast Company
200 Hidden Valley Rd.
Mcmurray,  PA  15317
Applicant Contact DONALD A STEVENS
Correspondent
Stelkast Company
200 Hidden Valley Rd.
Mcmurray,  PA  15317
Correspondent Contact DONALD A STEVENS
Regulation Number888.3560
Classification Product Code
JWH  
Date Received05/23/2008
Decision Date 06/06/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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