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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinous Process Plate
510(k) Number K142213
Device Name VIA SPINOUS PROCESS FIXATION SYSTEM
Applicant
Spineology, Inc.
7800 3rd St. N.
St. Paul,  MN  55128
Applicant Contact TIM CRABTREE
Correspondent
Spineology, Inc.
7800 3rd St. N.
St. Paul,  MN  55128
Correspondent Contact TIM CRABTREE
Regulation Number888.3050
Classification Product Code
PEK  
Date Received08/12/2014
Decision Date 09/10/2014
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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