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FDA 510(k), K122698, AEQUALIS ASCEND FLEX SHOULDER SYSTEM
FDA 510(k), K122698, AEQUALIS ASCEND FLEX SHOULDER SYSTEM
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510(K) Number: K122698
Device Name: AEQUALIS ASCEND FLEX SHOULDER SYSTEM
Manufacturer: Tornier SAS
Device Classification Name: prosthesis, shoulder, semi-constrained, metal/polymer cemented
Regulation Number: 888.3660
Classification Product Code: KWS
Date Received: 09/04/2012
Decision Date: 01/08/2013
Regulation Medical Specialty: Orthopedic
Device Name: AEQUALIS ASCEND FLEX SHOULDER SYSTEM
Manufacturer: Tornier SAS
Device Classification Name: prosthesis, shoulder, semi-constrained, metal/polymer cemented
Regulation Number: 888.3660
Classification Product Code: KWS
Date Received: 09/04/2012
Decision Date: 01/08/2013
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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