PMA P060037S010
- Device
- ZIMMER NEXGEN LPS-FLEX MOBILE/LPS-MOBILE BEARING KNEE SYSTEMS
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S010
- Product code
- NJL
- Decision date
- 2009-06-19
- Classification
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- APPROVAL FOR: 1) ADDING A VERIFICATION STEP TO USE A POKE-YOKE FIXTURE TO SORT PRODUCT DURING MANUFACTURING; AND 2) ADDING A STEP TO VERIFY THE SPIRALOCK THREAD FUNCTION.
Current openFDA PMA Record#
- Device
- ZIMMER NEXGEN LPS-FLEX MOBILE/LPS-MOBILE BEARING KNEE SYSTEMS
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S010
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2009-06-19
- Decision code
- APPR
- Date received
- 2009-05-22
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR: 1) ADDING A VERIFICATION STEP TO USE A POKE-YOKE FIXTURE TO SORT PRODUCT DURING MANUFACTURING; AND 2) ADDING A STEP TO VERIFY THE SPIRALOCK THREAD FUNCTION.