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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 K161407
Device Name Ascential IBD PEEKc Spacer
Applicant
Stryker Spine
2 Pearl Court
Allendale,  NJ  07401
Applicant Contact Tina Mornak
Correspondent
Stryker Spine
2 Pearl Court
Allendale,  NJ  07401
Correspondent Contact Tina Mornak
Regulation Number888.3080
Classification Product Code
ODP  
Date Received05/20/2016
Decision Date 07/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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