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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 K153525
Device Name Seneka II Polyscrew Pedicle Fixation System
Applicant
Senecka Spine
46 Harrison St.
Johnson City,  NY  13790
Applicant Contact Khalid Sethi
Correspondent
Silver Pine Consulting, LLC
11821 Bramble Cove Dr.
Fr. Myers,  FL  33905
Correspondent Contact Rich Jansen
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received12/09/2015
Decision Date 01/28/2016
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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