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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 K212135
Device Name Dry DBM- A Putty
Applicant
Seaspine Corporation
2 Goodyear
Irvine,  CA  92618
Applicant Contact Caryn Sailor
Correspondent
Seaspine Corporation
2 Goodyear
Irvine,  CA  92618
Correspondent Contact Caryn Sailor
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
MBP  
Date Received07/08/2021
Decision Date 10/04/2021
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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