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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, Porous Uncemented
510(k) Number K964509
Device Name IMPLEX A-240 HEP ACETABULAR CUP SYSTEM
Applicant
IMPLEX CORP.
1700 ROCKVILLE PIKE
SUITE 450
ROCKVILLE,  MD  20852
Applicant Contact GLENN N BYRD
Correspondent
IMPLEX CORP.
1700 ROCKVILLE PIKE
SUITE 450
ROCKVILLE,  MD  20852
Correspondent Contact GLENN N BYRD
Regulation Number888.3358
Classification Product Code
LPH  
Date Received11/08/1996
Decision Date 06/19/1997
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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