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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 K081880
Device Name ATLAS SPINE SPACER
Applicant
Atlas Spine, Inc.
1555 Jupiter Park Dr., Suite 4
Jupiter,  FL  33458
Applicant Contact JEANNETTE G DAILEY
Correspondent
Atlas Spine, Inc.
1555 Jupiter Park Dr., Suite 4
Jupiter,  FL  33458
Correspondent Contact JEANNETTE G DAILEY
Regulation Number888.3080
Classification Product Code
ODP  
Date Received07/02/2008
Decision Date 10/02/2008
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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