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FDA 510(k), K223548, GMK Sphere & GMK SpheriKA Cementless
FDA 510(k), K223548, GMK Sphere & GMK SpheriKA Cementless
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510(K) Number: K223548
Device Name: GMK Sphere & GMK SpheriKA Cementless
Manufacturer: Medacta International S.A.
Device Classification Name: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Regulation Number: 888.3565
Classification Product Code: MBH
Date Received: 11/25/2022
Decision Date: 01/20/2023
Regulation Medical Specialty: Orthopedic
Device Name: GMK Sphere & GMK SpheriKA Cementless
Manufacturer: Medacta International S.A.
Device Classification Name: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Regulation Number: 888.3565
Classification Product Code: MBH
Date Received: 11/25/2022
Decision Date: 01/20/2023
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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