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FDA 510(k), K110598, SMR REVERSE SHOULDER SYSTEM
FDA 510(k), K110598, SMR REVERSE SHOULDER SYSTEM
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510(K) Number: K110598
Device Name: SMR REVERSE SHOULDER SYSTEM
Manufacturer: LIMACORPORATE S.P.A.
Device Classification Name: shoulder prosthesis, reverse configuration
Regulation Number: 888.3660
Classification Product Code: PHX
Date Received: 03/02/2011
Decision Date: 08/18/2011
Regulation Medical Specialty: Orthopedic
Device Name: SMR REVERSE SHOULDER SYSTEM
Manufacturer: LIMACORPORATE S.P.A.
Device Classification Name: shoulder prosthesis, reverse configuration
Regulation Number: 888.3660
Classification Product Code: PHX
Date Received: 03/02/2011
Decision Date: 08/18/2011
Regulation Medical Specialty: Orthopedic
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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