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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 K052398
Device Name MESA SPINAL SYSTEM
Applicant
K2M, LLC
751 MILLER DR.,S.E., SUITE F1
LEESBURG,  VA  20175
Applicant Contact RICHARD W WOODS
Correspondent
K2M, LLC
751 MILLER DR.,S.E., SUITE F1
LEESBURG,  VA  20175
Correspondent Contact RICHARD W WOODS
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received08/31/2005
Decision Date 12/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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