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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 K081673
Device Name DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE
Applicant
Ionics Medical Corp.
248 Bird Haven Ln.
Ether,  NC  27247
Applicant Contact M. LAINE MASHBUM
Correspondent
Ionics Medical Corp.
248 Bird Haven Ln.
Ether,  NC  27247
Correspondent Contact M. LAINE MASHBUM
Regulation Number888.3080
Classification Product Code
MAX  
Date Received06/13/2008
Decision Date 11/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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