PMA P060037S046
- Device
- NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S046
- Product code
- NJL
- Decision date
- 2016-09-01
- Classification
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- Addition of Ambatovy Cobalt and Novotroisk Chromium, as second-tier approved raw material suppliers of Zimaloy Cobalt-Chromium-Molybdenum-Alloy Continuous Cast Ignot, used in the manufacture of the femoral components of the NexGen LPS-Flex/LPS Mobile Bearing Knee System.
Current openFDA PMA Record#
- Device
- NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S046
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2016-09-01
- Decision code
- OK30
- Date received
- 2016-08-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of Ambatovy Cobalt and Novotroisk Chromium, as second-tier approved raw material suppliers of Zimaloy Cobalt-Chromium-Molybdenum-Alloy Continuous Cast Ignot, used in the manufacture of the femoral components of the NexGen LPS-Flex/LPS Mobile Bearing Knee System.