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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, Cement Restrictor
510(k) Number K041583
Device Name PEEK CEMENT RESTRICTOR X-BOX
Applicant
Innovasis, Inc.
997 E. 3900 S.
Suite 103
Salt Lake City,  UT  84124
Applicant Contact BRENT A FELIX
Correspondent
Innovasis, Inc.
997 E. 3900 S.
Suite 103
Salt Lake City,  UT  84124
Correspondent Contact BRENT A FELIX
Regulation Number878.3300
Classification Product Code
JDK  
Date Received06/11/2004
Decision Date 07/22/2004
Decision SE - With Limitations (SESU)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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