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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, toe, constrained, polymer
510(k) Number K190136
Device Name Fusion Silastic System
Applicant
Fusion Orthopedics, LLC
4135 S. Power Rd., Suite 110
Mesa,  AZ  85212
Applicant Contact Eli Jacobson
Correspondent
Fusion Orthopedics, LLC
4135 S. Power Rd., Suite 110
Mesa,  AZ  85212
Correspondent Contact Eli Jacobson
Regulation Number888.3720
Classification Product Code
KWH  
Date Received01/29/2019
Decision Date 10/21/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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