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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, Cervical
510(k) Number K171496
Device Name Tritanium C Anterior Cervical Cage
Applicant
Stryker Spine
2 Pearl Court
Allendale,  NJ  07401
Applicant Contact Deborah Cynamon
Correspondent
Stryker Spine
2 Pearl Court
Allendale,  NJ  07401
Correspondent Contact Deborah Cynamon
Regulation Number888.3080
Classification Product Code
ODP  
Date Received05/22/2017
Decision Date 09/06/2017
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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