NEXGEN LPS-FLEX/LPS-MOBILE BEARING KNEE
FDA premarket approval P060037/S013 · decided 2010-10-20
Approval details
- PMA number
- P060037
- Supplement
- S013
- Supplement type
- Special (Immediate Track)
- Trade name
- NEXGEN LPS-FLEX/LPS-MOBILE BEARING KNEE
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Zimmer, Inc.
- Date received
- 2010-05-12
- Decision date
- 2010-10-20
- Days to decision
- 161 days
- Decision code
- APPR
- Product code
- NJL
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR THE ADDITION OF AN INSPECTION STEP FOR THE FLUTED STEM MOBILE TIBIAL BASEPLATE ENGRAVED LINE FEATURE.
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510(k) clearances by this applicant
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