PMA P060037S044
- Device
- NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S044
- Product code
- NJL
- Decision date
- 2016-04-29
- Classification
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- to discontinue redundant in-house testing of Ultra High Molecular Weight Polyethylene (UHMWPE) used in the LPS-Mobile Articular Surface components (i.e., tibial inserts) upon its receipt at Zimmer
Current openFDA PMA Record#
- Device
- NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S044
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2016-04-29
- Decision code
- OK30
- Date received
- 2016-03-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to discontinue redundant in-house testing of Ultra High Molecular Weight Polyethylene (UHMWPE) used in the LPS-Mobile Articular Surface components (i.e., tibial inserts) upon its receipt at Zimmer