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FDA 510(k), K122160, VANGUARD XP KNEE SYSTEM
FDA 510(k), K122160, VANGUARD XP KNEE SYSTEM
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510(K) Number: K122160
Device Name: VANGUARD XP KNEE SYSTEM
Manufacturer: BIOMET MANUFACTURING CORP.
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: 07/20/2012
Decision Date: 03/20/2013
Regulation Medical Specialty: Orthopedic
Device Name: VANGUARD XP KNEE SYSTEM
Manufacturer: BIOMET MANUFACTURING CORP.
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: 07/20/2012
Decision Date: 03/20/2013
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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