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FDA 510(k), K110599, AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
FDA 510(k), K110599, AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
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510(K) Number: K110599
Device Name: AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
Manufacturer: TORNIER, INC.
Device Classification Name: shoulder prosthesis, reverse configuration
Regulation Number: 888.3660
Classification Product Code: PHX
Date Received: 03/02/2011
Decision Date: 06/14/2011
Regulation Medical Specialty: Orthopedic
Device Name: AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
Manufacturer: TORNIER, INC.
Device Classification Name: shoulder prosthesis, reverse configuration
Regulation Number: 888.3660
Classification Product Code: PHX
Date Received: 03/02/2011
Decision Date: 06/14/2011
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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