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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 uncemented acetabular component)
510(k) Number K001536
Device Name INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS
Original Applicant
SULZER ORTHOPEDICS, INC.
9900 spectrum dr.
austin,  TX  78717
Original Contact mitchell a dhority
Regulation Number888.3330
Classification Product Code
KWA  
Date Received05/17/2000
Decision Date 07/27/2000
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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