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FDA 510(k), K153657, Vanguard XP Knee System
FDA 510(k), K153657, Vanguard XP Knee System
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510(K) Number: K153657
Device Name: Vanguard XP Knee System
Manufacturer: BIOMET, INC.
Device Classification Name: prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
Regulation Number: 888.3565
Classification Product Code: MBH
Date Received: 12/21/2015
Decision Date: 05/10/2016
Regulation Medical Specialty: Orthopedic
Device Name: Vanguard XP Knee System
Manufacturer: BIOMET, INC.
Device Classification Name: prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
Regulation Number: 888.3565
Classification Product Code: MBH
Date Received: 12/21/2015
Decision Date: 05/10/2016
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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