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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 K123180
Device Name FALCON SPACER
Applicant
Synthes (USA) Products, LLC
1302 Wrights Lane E.
West Chester,  PA  19380
Applicant Contact MONIKA MCDOLE-RUSSELL
Correspondent
Synthes (USA) Products, LLC
1302 Wrights Lane E.
West Chester,  PA  19380
Correspondent Contact MONIKA MCDOLE-RUSSELL
Regulation Number888.3080
Classification Product Code
MAX  
Date Received10/10/2012
Decision Date 01/08/2013
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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