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FDA 510(k), K193067, The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System
FDA 510(k), K193067, The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System
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510(K) Number: K193067
Device Name: The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System
Manufacturer: Wright Medical Technology, Inc.
Device Classification Name: Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Regulation Number: 888.3110
Classification Product Code: HSN
Date Received: 11/04/2019
Decision Date: 06/08/2020
Regulation Medical Specialty: Orthopedic
Device Name: The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System
Manufacturer: Wright Medical Technology, Inc.
Device Classification Name: Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Regulation Number: 888.3110
Classification Product Code: HSN
Date Received: 11/04/2019
Decision Date: 06/08/2020
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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