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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 K200290
Device Name Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)
Applicant
SeaSpine Orthopedics Corporation
2 Goodyear
Irvine,  CA  92618
Applicant Contact Caryn Sailor
Correspondent
SeaSpine Orthopedics Corporation
2 Goodyear
Irvine,  CA  92618
Correspondent Contact Caryn Sailor
Regulation Number888.3045
Classification Product Code
MQV  
Date Received02/05/2020
Decision Date 05/11/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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