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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name syringe, piston
510(k) Number K221737
Device Name InstaFill Graft Delivery System, SIGNIFY Bioactive
Applicant
Globus Medical Inc.
2560 General Armistead Ave.
Audubon,  PA  19403
Applicant Contact Jennifer Antonacci
Correspondent
Globus Medical Inc.
2560 General Armistead Ave.
Audubon,  PA  19403
Correspondent Contact Jennifer Antonacci
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
MQV  
Date Received06/15/2022
Decision Date 08/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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