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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
510(k) Number K241219
Device Name FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)
Applicant
ZuriMED Technologies AG
Lengghalde 5
Zurich,  CH 8008
Applicant Contact Elias Bachman
Correspondent
Hogan Lovells US LLP
1735 Market St.
Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number878.3300
Classification Product Code
OWX  
Date Received05/01/2024
Decision Date 12/11/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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