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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 K072118
Device Name STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT
Applicant
Stryker Corp.
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Applicant Contact JEAN SHEPPARD
Correspondent
Stryker Corp.
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Correspondent Contact JEAN SHEPPARD
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Code
LOD  
Date Received08/01/2007
Decision Date 12/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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