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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 K180475
Device Name CapLOX II® / TowerLOX® MIS Pedicle Screw System
Applicant
Captiva Spine, Inc.
967 N. Alternate A1a, Suite 1
Jupiter,  FL  33477
Applicant Contact Jackie Ferro
Correspondent
Captiva Spine, Inc.
967 N. Alternate A1a, Suite 1
Jupiter,  FL  33477
Correspondent Contact Jackie Ferro
Regulation Number888.3070
Classification Product Code
NKB  
Date Received02/22/2018
Decision Date 03/19/2018
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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