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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 K133328
Device Name AERO-AL LUMBAR CAGE SYSTEM
Applicant
Stryker Corporation
2 Pearl Ct.
Allendale,  NJ  07401
Applicant Contact TIFFANI ROGERS
Correspondent
Stryker Corporation
2 Pearl Ct.
Allendale,  NJ  07401
Correspondent Contact TIFFANI ROGERS
Regulation Number888.3080
Classification Product Code
OVD  
Date Received10/29/2013
Decision Date 05/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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