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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 K091717
Device Name ANY PLUS SPINAL FIXATION SYSTEM
Applicant
GS Medical Co., Ltd.
220 River Rd.
Claremont,  NH  03743
Applicant Contact WILLIAM F GREENROSE
Correspondent
GS Medical Co., Ltd.
220 River Rd.
Claremont,  NH  03743
Correspondent Contact WILLIAM F GREENROSE
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received06/11/2009
Decision Date 01/25/2010
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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