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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K220812
Device Name DynaClip® Bone Staple
Applicant
MedShape, Inc.
1575 Northside Dr. NW, Suite 440
Atlanta,  GA  30318
Applicant Contact Courtney Kline
Correspondent
MedShape, Inc.
1575 Northside Dr. NW, Suite 440
Atlanta,  GA  30318
Correspondent Contact Courtney Kline
Regulation Number888.3030
Classification Product Code
JDR  
Date Received03/21/2022
Decision Date 08/19/2022
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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