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FDA 510(k), K221479, Persona Personalized Knee System
FDA 510(k), K221479, Persona Personalized Knee System
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510(K) Number: K221479
Device Name: Persona Personalized Knee System
Manufacturer: Gregory Foster
Device Classification Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Regulation Number: JWH
Classification Product Code: KXA
Date Received: 05/23/2022
Decision Date: 11/17/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: Persona Personalized Knee System
Manufacturer: Gregory Foster
Device Classification Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Regulation Number: JWH
Classification Product Code: KXA
Date Received: 05/23/2022
Decision Date: 11/17/2022
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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