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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 K141850
Device Name FLOSPINE PEDICLE SCREW SYSTEM
Applicant
Flospine
11821 Bramble Cove Dr.
Fr. Myers,  FL  33905
Applicant Contact RICH JANSEN
Correspondent
Flospine
11821 Bramble Cove Dr.
Fr. Myers,  FL  33905
Correspondent Contact RICH JANSEN
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI   OSH  
Date Received07/09/2014
Decision Date 10/27/2014
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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