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FDA 510(k), K160700, ATTUNE Revision Knee System
FDA 510(k), K160700, ATTUNE Revision Knee System
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510(K) Number: K160700
Device Name: ATTUNE Revision Knee System
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: 03/14/2016
Decision Date: 06/10/2016
Regulation Medical Specialty: Orthopedic
Device Name: ATTUNE Revision Knee System
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: 03/14/2016
Decision Date: 06/10/2016
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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