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FDA 510(k), K090139, ANKLE ARTHRODESIS PLATE SYSTEM
FDA 510(k), K090139, ANKLE ARTHRODESIS PLATE SYSTEM
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510(K) Number: K090139
Device Name: ANKLE ARTHRODESIS PLATE SYSTEM
Manufacturer: BRAHIM HADRI
Device Classification Name: Plate, Fixation, Bone
Regulation Number: HRS
Classification Product Code: KXA
Date Received: 01/21/2009
Decision Date: 10/27/2009
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: ANKLE ARTHRODESIS PLATE SYSTEM
Manufacturer: BRAHIM HADRI
Device Classification Name: Plate, Fixation, Bone
Regulation Number: HRS
Classification Product Code: KXA
Date Received: 01/21/2009
Decision Date: 10/27/2009
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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