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FDA 510(k), K140082, AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM
FDA 510(k), K140082, AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM
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510(K) Number: K140082
Device Name: AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM
Manufacturer: Tornier SAS
Device Classification Name: shoulder prosthesis, reverse configuration
Regulation Number: 888.3660
Classification Product Code: PHX
Date Received: 01/13/2014
Decision Date: 07/18/2014
Regulation Medical Specialty: Orthopedic
Device Name: AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM
Manufacturer: Tornier SAS
Device Classification Name: shoulder prosthesis, reverse configuration
Regulation Number: 888.3660
Classification Product Code: PHX
Date Received: 01/13/2014
Decision Date: 07/18/2014
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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