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FDA 510(k), K103332, APTUS ULNA PLATES
FDA 510(k), K103332, APTUS ULNA PLATES
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510(K) Number: K103332
Device Name: APTUS ULNA PLATES
Manufacturer: KEVIN A THOMAS
Device Classification Name: Plate, Fixation, Bone
Regulation Number: HRS
Classification Product Code: KXA
Date Received: 11/12/2010
Decision Date: 01/24/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: APTUS ULNA PLATES
Manufacturer: KEVIN A THOMAS
Device Classification Name: Plate, Fixation, Bone
Regulation Number: HRS
Classification Product Code: KXA
Date Received: 11/12/2010
Decision Date: 01/24/2011
Decision: Substantially Equivalent (SESE)
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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