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FDA 510(k), K123954, INFINITY TOTAL ANKLE SYSTEM
FDA 510(k), K123954, INFINITY TOTAL ANKLE SYSTEM
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510(K) Number: K123954
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: 12/21/2012
Decision Date: 04/01/2013
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: 12/21/2012
Decision Date: 04/01/2013
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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