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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 K140787
Device Name PLS (POSTERIOR LUMBAR SYSTEM)
Applicant
Sintea Plustek, LLC
11821 Bramble Cove Dr.
Fr. Myers,  FL  33905
Applicant Contact RICH JANSEN
Correspondent
Sintea Plustek, LLC
11821 Bramble Cove Dr.
Fr. Myers,  FL  33905
Correspondent Contact RICH JANSEN
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   MNI  
Date Received03/31/2014
Decision Date 05/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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