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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 K171568
Device Name SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty
Applicant
Hans Biomed Corporation
64, Yuseong-Daero 1628 Beon-Gil
Yuseong-Gu
Daejeon,  KR 34054
Applicant Contact Lucy Choi
Correspondent
Trisler Consulting
5600 Wisconsin Ave., # 509
Chevy Chase,  MD  20815
Correspondent Contact Patsy J. Trisler
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
MBP  
Date Received05/30/2017
Decision Date 02/22/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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