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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 K000817
Device Name OMEGA II MODULAR TOTAL HIP SYSTEM
Applicant
OSTEOIMPLANT TECHNOLOGY, INC.
11201 PEPPER RD.
HUNT VALLEY,  MD  21031 -1201
Applicant Contact SAM SON
Correspondent
OSTEOIMPLANT TECHNOLOGY, INC.
11201 PEPPER RD.
HUNT VALLEY,  MD  21031 -1201
Correspondent Contact SAM SON
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Code
LPH  
Date Received03/13/2000
Decision Date 06/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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