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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K173189
Device Name Lumfuse TP
Applicant
Precifit Medical Ltd
2233 5th Street East
St Paul,  MN  55119
Applicant Contact Zhen Yu (Eric) Wu
Correspondent
Orchid Design
4600 E Shelby Dr
Memphis,  TN  38118
Correspondent Contact Kellen Hills
Regulation Number888.3080
Classification Product Code
MAX  
Date Received10/02/2017
Decision Date 06/08/2018
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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