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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 K051371
Device Name INTERBODY INNOVATIONS CEMENT RESTRICTOR
Applicant
Interbody Innovations, Llp
2454 Mcmullen Booth Rd.
Suite 427
Clearwater,  FL  33759
Applicant Contact IAN GORDON
Correspondent
Interbody Innovations, Llp
2454 Mcmullen Booth Rd.
Suite 427
Clearwater,  FL  33759
Correspondent Contact IAN GORDON
Regulation Number878.3300
Classification Product Code
JDK  
Date Received05/26/2005
Decision Date 12/06/2005
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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