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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cement, bone, vertebroplasty
510(k) Number K043593
Device Name SPINE-FIX BIOMIMETIC BONE CEMENT
Applicant
TEKNIMED SA
1001 OAKWOOD BLVD
ROUND ROCK,  TX  78681
Applicant Contact J. D. WEBB
Correspondent
TEKNIMED SA
1001 OAKWOOD BLVD
ROUND ROCK,  TX  78681
Correspondent Contact J. D. WEBB
Regulation Number888.3027
Classification Product Code
NDN  
Date Received12/29/2004
Decision Date 03/17/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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