PMA P060037S062
- Device
- NexGen LPS-Flex/LPS-Mobile Bearing Knee
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S062
- Product code
- NJL
- Decision date
- 2019-10-24
- Classification
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- Change in the density range of gamma sterilization from 0.09 to 0.2 g/cm3 to 0.05 to 0.15 g/cm3. The density range is used in the gamma sterilization of NexGen® LPSFlex/LPS-Mobile Bearing Knee manufactured at Zimmer Orthopedics Manufacturing Limited (ZOML) Shannon Ireland facility.
Current openFDA PMA Record#
- Device
- NexGen LPS-Flex/LPS-Mobile Bearing Knee
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S062
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2019-10-24
- Decision code
- OK30
- Date received
- 2019-09-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the density range of gamma sterilization from 0.09 to 0.2 g/cm3 to 0.05 to 0.15 g/cm3. The density range is used in the gamma sterilization of NexGen® LPSFlex/LPS-Mobile Bearing Knee manufactured at Zimmer Orthopedics Manufacturing Limited (ZOML) Shannon Ireland facility.