FDA 510(k) Applications for Medical Device Product Code "OWX"

FDA 510(k) Number Applicant Device Name Decision Date
K223538 Anika Therapeutics, Inc. Integrity Implant 08/17/2023
K250997 Anika Therapeutics, Inc. IntegrityÖ Implant 06/17/2025
K243480 Arthrex Inc. SuturePatch Tissue Reinforcement 05/29/2025
K241219 ZuriMed Technologies AG FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) 12/11/2024


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