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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 K231714
Device Name Graftys Quickset
Applicant
Graftys
415 Rue Claude Nicolas Ledoux
Eiffel Park Bat. D
Aix En Provence,  FR 13854
Applicant Contact Cedric Bonneau
Correspondent
Graftys
415 Rue Claude Nicolas Ledoux
Eiffel Park Bat. D
Aix En Provence,  FR 13854
Correspondent Contact Cedric Bonneau
Regulation Number888.3045
Classification Product Code
MQV  
Date Received06/12/2023
Decision Date 07/12/2023
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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