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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, hip, semi-constrained, metal/polymer, cemented
510(k) Number K961890
Device Name FOUNDATION 9MM FORGED CEMENTED STEM
Applicant
ENCORE ORTHOPEDICS, INC.
8900 SHOAL CREEK BLVD.,
BLDG. 300
AUSTIN,  TX  78757
Applicant Contact ASHLEY M BOCK
Correspondent
ENCORE ORTHOPEDICS, INC.
8900 SHOAL CREEK BLVD.,
BLDG. 300
AUSTIN,  TX  78757
Correspondent Contact ASHLEY M BOCK
Regulation Number888.3350
Classification Product Code
JDI  
Date Received05/15/1996
Decision Date 06/14/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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