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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 K093343
Device Name GRAFTY QUICKSET
Applicant
Graftys
415 Rue Charles Nicolas Ledoux
Eiffel Park Bat D
Aix En Provence,  FR 13854
Applicant Contact ANTHONY LE NAOUR
Correspondent
Graftys
415 Rue Charles Nicolas Ledoux
Eiffel Park Bat D
Aix En Provence,  FR 13854
Correspondent Contact ANTHONY LE NAOUR
Regulation Number888.3045
Classification Product Code
MQV  
Date Received10/26/2009
Decision Date 04/22/2010
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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