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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 K102606
Device Name AVS ANCHOR-C CERVICAL CAGE SYSTEM
Applicant
Stryker Spine
2 Pearl Ct.
Allendale,  NJ  07401
Applicant Contact KIMBERLY LANE
Correspondent
Stryker Spine
2 Pearl Ct.
Allendale,  NJ  07401
Correspondent Contact KIMBERLY LANE
Regulation Number888.3080
Classification Product Code
OVE  
Date Received09/10/2010
Decision Date 04/22/2011
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
Recalls CDRH Recalls
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