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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, Lumbar
510(k) Number K131276
Device Name LATERAL SYNFIX
Applicant
Synthes (USA) Products, LLC
1302 Wrights Ln. E.
West Chester,  PA  19380
Applicant Contact MONIKA MCDOLE-RUSSELL
Correspondent
Synthes (USA) Products, LLC
1302 Wrights Ln. E.
West Chester,  PA  19380
Correspondent Contact MONIKA MCDOLE-RUSSELL
Regulation Number888.3080
Classification Product Code
OVD  
Date Received05/06/2013
Decision Date 01/06/2014
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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