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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K172130
Device Name Resorbable Mesh Device
Applicant
SeaSpine Orthopedics Corporation
2 Goodyear
Irvine,  CA  92618
Applicant Contact Jenny Fam
Correspondent
SeaSpine Orthopedics Corporation
5770 Armada Dr.
Carlsbad,  CA  98008
Correspondent Contact Caryn Sailor
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
MBP  
Date Received07/14/2017
Decision Date 11/16/2017
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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