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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 K092640
Device Name CASPIAN SPINAL SYSTEM
Applicant
K2m,Inc.
751 Miller Dr. SE
Leesburg,  VA  20175
Applicant Contact RICHARD W WOODS
Correspondent
K2m,Inc.
751 Miller Dr. SE
Leesburg,  VA  20175
Correspondent Contact RICHARD W WOODS
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
KWP  
Date Received08/27/2009
Decision Date 11/06/2009
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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