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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 K182507
Device Name Tigon Medical Tissue Anchors
Applicant
Tigon Medical
517 Benfield Rd.
Severna Park,  MD  21146
Applicant Contact Jeremy Clark
Correspondent
Intrepid Orthopedics, LLC
3953 Humphrey Rd.
Richfield,  OH  44286
Correspondent Contact Lee Strnad
Regulation Number888.3040
Classification Product Code
MBI  
Date Received09/12/2018
Decision Date 01/21/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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