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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthosis, spondylolisthesis spinal fixation
510(k) Number K122994
Device Name INTRAMEDULLARY NAIL SYSTEM
Applicant
WEIGAO ORTHOPAEDIC DEVICE CO., LTD
po box 237-023
shanghai,  CN 200237
Applicant Contact diana hong
Correspondent
WEIGAO ORTHOPAEDIC DEVICE CO., LTD
po box 237-023
shanghai,  CN 200237
Correspondent Contact diana hong
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   MNI  
Date Received09/27/2012
Decision Date 04/12/2013
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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