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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 K120464
Device Name INNESIS PEEK CAGE
Applicant
BK MEDITECH CO., LTD.
8 EAST BROADWAY, STE 611
SALT LAKE CITY,  UT  84111
Applicant Contact SHIN KUK YOO
Correspondent
BK MEDITECH CO., LTD.
8 EAST BROADWAY, STE 611
SALT LAKE CITY,  UT  84111
Correspondent Contact SHIN KUK YOO
Regulation Number888.3080
Classification Product Code
MAX  
Date Received02/15/2012
Decision Date 01/18/2013
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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