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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 Integrated Fixation, Cervical
510(k) Number K113796
FOIA Releasable 510(k) K113796
Device Name SOLITAIRE-C CERVICAL SPACER SYSTEM
Applicant
EBI, LLC
399 Jefferson Rd
PARSIPPANY,  NJ  07054
Applicant Contact MARGARET CROWE
Correspondent
EBI, LLC
399 Jefferson Rd
PARSIPPANY,  NJ  07054
Correspondent Contact MARGARET CROWE
Regulation Number888.3080
Classification Product Code
OVE  
Date Received12/23/2011
Decision Date 04/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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