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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K021379
Device Name SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06
Applicant
Ortho Tec, LLC
8202 Sherman Rd.
Chesterland,  OH  44026 -2141
Applicant Contact KAREN E WARDEN
Correspondent
Ortho Tec, LLC
8202 Sherman Rd.
Chesterland,  OH  44026 -2141
Correspondent Contact KAREN E WARDEN
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   KWQ   MNH  
Date Received05/01/2002
Decision Date 05/31/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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