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FDA 510(k), K181557, INFINITY Total Ankle System
FDA 510(k), K181557, INFINITY Total Ankle System
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510(K) Number: K181557
Device Name: INFINITY Total Ankle 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: 06/13/2018
Decision Date: 08/09/2018
Regulation Medical Specialty: Orthopedic
Device Name: INFINITY Total Ankle 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: 06/13/2018
Decision Date: 08/09/2018
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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