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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 K121581
Device Name BOX PEEK VBR SYSTEM,
Applicant
INNOVASIS, INC.
614 EAST 3900 SOUTH
SALT LAKE CITY,  UT  84107
Applicant Contact MARSHALL C MCCARTY
Correspondent
INNOVASIS, INC.
614 EAST 3900 SOUTH
SALT LAKE CITY,  UT  84107
Correspondent Contact MARSHALL C MCCARTY
Regulation Number888.3080
Classification Product Code
MAX  
Date Received05/30/2012
Decision Date 10/17/2012
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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