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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 K120538
Device Name PALLS M SPINAL SYSTEM
Original Applicant
KOREA BONE BANK CO., LTD
325 n puente st
unit b
brea,  CA  92821
Original Contact april lee
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received02/22/2012
Decision Date 03/23/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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