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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 K140046
Device Name SPINOUS PROCESS FUSION (SPF) PLATE
Applicant
Spinal Simplicity, LLC
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Applicant Contact JANICE M HOGAN
Correspondent
Spinal Simplicity, LLC
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Correspondent Contact JANICE M HOGAN
Regulation Number888.3050
Classification Product Code
PEK  
Date Received01/08/2014
Decision Date 01/09/2015
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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