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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 K092017
Device Name PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD)
Applicant
CAPTIVA SPINE, INC
PO BOX 1196
PLEASANT GROVE,  UT  84062
Applicant Contact MIKE ENSIGN
Correspondent
CAPTIVA SPINE, INC
PO BOX 1196
PLEASANT GROVE,  UT  84062
Correspondent Contact MIKE ENSIGN
Regulation Number888.3080
Classification Product Code
MAX  
Date Received07/06/2009
Decision Date 12/01/2009
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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