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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 K003758
Device Name ALLOFIT ACETABULAR SYSTEM
Applicant
SULZER ORTHOPEDICS, INC.
9900 spectrum dr.
austin,  TX  78717
Contact mitchell a dhority
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Code
LZO  
Date Received12/06/2000
Decision Date 03/07/2001
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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