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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K120074
Device Name FOUNDATION SPINAL SYSTEM
Applicant
The Skeletal Design Partnership , Ltd.
8202 Sherman Rd.
Chesterland,  OH  44026
Applicant Contact KAREN E WARDEN, PHD
Correspondent
The Skeletal Design Partnership , Ltd.
8202 Sherman Rd.
Chesterland,  OH  44026
Correspondent Contact KAREN E WARDEN, PHD
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received01/10/2012
Decision Date 03/14/2012
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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