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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K132122
Device Name KESTREL POSTERIOR CERVICAL SPINE SYSTEM
Applicant
Omni Surgical, LLC Dba Spine360
5000 Plz. On The Lake, Suite 305
Austin,  TX  78746
Applicant Contact DAVE LAMB
Correspondent
Omni Surgical, LLC Dba Spine360
5000 Plz. On The Lake, Suite 305
Austin,  TX  78746
Correspondent Contact DAVE LAMB
Regulation Number888.3050
Classification Product Code
KWP  
Date Received07/10/2013
Decision Date 01/22/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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