FDA 510(k), K163046, DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long

FDA 510(k), K163046, DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long

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510(K) Number: K163046
Device Name: DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long
Manufacturer: JOANNA RIEDER
Device Classification Name: Plate, Fixation, Bone
Regulation Number: HRS
Classification Product Code: KXA
Date Received: 11/01/2016
Decision Date: 02/09/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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