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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K081107
Device Name CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS
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 Number888.3050
Classification Product Code
KWP  
Date Received04/18/2008
Decision Date 10/10/2008
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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