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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K180990
Device Name TirboLOX-L Lumbar IBFD
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 Number888.3080
Classification Product Code
MAX  
Date Received04/16/2018
Decision Date 08/13/2018
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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