ZIMMER NEXGEN LPS-FLEX MOBILE & LPS MOBILE BEARING KNEE SYSTEMS
FDA premarket approval P060037/S009 · decided 2010-11-03
Approval details
- PMA number
- P060037
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ZIMMER NEXGEN LPS-FLEX MOBILE & LPS MOBILE BEARING KNEE SYSTEMS
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Zimmer, Inc.
- Date received
- 2009-04-24
- Decision date
- 2010-11-03
- Days to decision
- 558 days
- Decision code
- APPR
- Product code
- NJL
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR THE ADDITION OF PROLONG HIGHLY CROSSLINKED POLYETHYLENE TIBIAL ARTICULAR SURFACES TO THE NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM.
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