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FDA 510(k), K141735, ARTHREX ANKLE FUSION PLATING SYSTEM
FDA 510(k), K141735, ARTHREX ANKLE FUSION PLATING SYSTEM
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510(K) Number: K141735
Device Name: ARTHREX ANKLE FUSION PLATING SYSTEM
Manufacturer: LAURA MEDLIN
Device Classification Name: Plate, Fixation, Bone
Regulation Number: HRS
Classification Product Code: KXA
Date Received: 06/27/2014
Decision Date: 08/15/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: ARTHREX ANKLE FUSION PLATING SYSTEM
Manufacturer: LAURA MEDLIN
Device Classification Name: Plate, Fixation, Bone
Regulation Number: HRS
Classification Product Code: KXA
Date Received: 06/27/2014
Decision Date: 08/15/2014
Decision: Substantially Equivalent (SESE)
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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