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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 K091743
Device Name SEC VBR
Applicant
Innvotec Surgical, Inc.
1331 H St. NW
12th Floor
Washington,  DC  20005
Applicant Contact JUSTIN EGGLETON
Correspondent
Innvotec Surgical, Inc.
1331 H St. NW
12th Floor
Washington,  DC  20005
Correspondent Contact JUSTIN EGGLETON
Regulation Number888.3060
Classification Product Code
MQP  
Date Received06/16/2009
Decision Date 11/02/2009
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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