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FDA 510(k), K222501, Regeneten Bioinductive Implant
FDA 510(k), K222501, Regeneten Bioinductive Implant
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510(K) Number: K222501
Device Name: Regeneten Bioinductive Implant
Manufacturer: Jenna Horsley
Device Classification Name: Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Regulation Number: OWY
Classification Product Code: KXA
Date Received: 08/18/2022
Decision Date: 05/11/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: Regeneten Bioinductive Implant
Manufacturer: Jenna Horsley
Device Classification Name: Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Regulation Number: OWY
Classification Product Code: KXA
Date Received: 08/18/2022
Decision Date: 05/11/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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