FDA 510(k), K170806, ATTUNE Cemented Tibial Base, Fixed Bearing

FDA 510(k), K170806, ATTUNE Cemented Tibial Base, Fixed Bearing

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510(K) Number: K170806
Device Name: ATTUNE Cemented Tibial Base, Fixed Bearing
Manufacturer: DePuy (Ireland)
Device Classification Name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
Regulation Number: 888.3560
Classification Product Code: JWH
Date Received: 03/17/2017
Decision Date: 06/15/2017
Regulation Medical Specialty: Orthopedic
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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