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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, Cervical
510(k) Number K110585
Device Name CAPTIVA SPINE FUSELOX CERVICAL CAGE
Applicant
Captiva Spine, Inc.
2361 NW 105th Ln.
Sunrise,  FL  33322
Applicant Contact JOHN SANDERS
Correspondent
Captiva Spine, Inc.
2361 NW 105th Ln.
Sunrise,  FL  33322
Correspondent Contact JOHN SANDERS
Regulation Number888.3080
Classification Product Code
ODP  
Date Received03/01/2011
Decision Date 03/25/2011
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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