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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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