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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 K242273
Device Name Cove Putty, OsteoCove Putty
Applicant
SeaSpine Orthopedics Corporation
5770 Armada Dr.
Carlsbad,  CA  92008
Applicant Contact Patrick Hughes
Correspondent
SeaSpine Orthopedics Corporation
5770 Armada Dr.
Carlsbad,  CA  92008
Correspondent Contact Patrick Hughes
Regulation Number888.3045
Classification Product Code
MQV  
Date Received08/01/2024
Decision Date 09/25/2024
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
Recalls CDRH Recalls
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