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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K060118
Device Name SSP PEDICLE SCREW SYSTEM
Applicant
Specialty Spine Products, LLC
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Applicant Contact FLOYD G LARSON
Correspondent
Specialty Spine Products, LLC
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Correspondent Contact FLOYD G LARSON
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received01/17/2006
Decision Date 06/08/2006
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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