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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K222971
Device Name ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device
Applicant
Smith & Nephew, Inc.
150 Minuteman Rd.
Andover,  MA  01810
Applicant Contact Dongeun LoPresti
Correspondent
Smith & Nephew, Inc.
150 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact Dongeun LoPresti
Regulation Number888.3040
Classification Product Code
MBI  
Date Received09/27/2022
Decision Date 02/17/2023
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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