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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 cemented acetabular component)
510(k) Number K922861
Device Name BIOMETRIC SCREW FIXATION CUP
Applicant
OSTEO TECHNOLOGY, INC.
10 WEST AYLESBURY RD.
TIMONIUM,  MD  21093
Applicant Contact SAM SON
Correspondent
OSTEO TECHNOLOGY, INC.
10 WEST AYLESBURY RD.
TIMONIUM,  MD  21093
Correspondent Contact SAM SON
Regulation Number888.3320
Classification Product Code
JDL  
Date Received06/04/1992
Decision Date 05/12/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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