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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K101886
Device Name DSC/ALF SPINAL SYSTEM
Applicant
Sintea Plastek, LLC
407 Lincoln Rd.
Suite 101
Miami Beach,  FL  33139
Applicant Contact DANIELLE WERNIKOWSKI
Correspondent
Sintea Plastek, LLC
407 Lincoln Rd.
Suite 101
Miami Beach,  FL  33139
Correspondent Contact DANIELLE WERNIKOWSKI
Regulation Number888.3060
Classification Product Code
MQP  
Subsequent Product Code
KWQ  
Date Received07/06/2010
Decision Date 07/21/2011
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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