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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hip prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
510(k) Number K122773
Device Name CROSS-OVER ACETABULAR SHELL & LINER
Applicant
STELKAST COMPANY
200 HIDDEN VALLEY RD.
MCMURRAY,  PA  15317
Applicant Contact DAVID STUMPO
Correspondent
STELKAST COMPANY
200 HIDDEN VALLEY RD.
MCMURRAY,  PA  15317
Correspondent Contact DAVID STUMPO
Regulation Number888.3358
Classification Product Code
OQG  
Subsequent Product Codes
JDI   LPH   LWJ   LZO   MAY  
OQH   OQI  
Date Received09/10/2012
Decision Date 10/09/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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