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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 K091381
Device Name IBEX SPINAL SYSTEM
Applicant
Ebi, L.P.
399 Jefferson Rd.
Parsippany,  NJ  07054
Applicant Contact VIVIAN KELLY
Correspondent
Ebi, L.P.
399 Jefferson Rd.
Parsippany,  NJ  07054
Correspondent Contact VIVIAN KELLY
Regulation Number888.3080
Classification Product Code
MAX  
Date Received05/11/2009
Decision Date 08/07/2009
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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