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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 K160020
Device Name Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System
Applicant
Captiva Spine
967 N. Alternate A1a, Suite 1
Jupiter,  FL  33477
Applicant Contact Tamala J. Wampler
Correspondent
Empirical Testing Corp
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Kennneth C. Maxwell
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received01/05/2016
Decision Date 03/02/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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