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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K071921
Device Name INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS)
Applicant
Innovasis, Inc.
614 E 3900 S
Salt Lake City,  UT  84107
Applicant Contact WARREN DANSIE
Correspondent
Innovasis, Inc.
614 E 3900 S
Salt Lake City,  UT  84107
Correspondent Contact WARREN DANSIE
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received07/12/2007
Decision Date 11/16/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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