PMA P830055S091
- Device
- LCS TOTAL KNEE SYSTEM
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S091
- Product code
- NJL
- Decision date
- 2005-09-12
- 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 A CHANGE IN THE CRITERIA USED IN THE MANUFACTURE OF THE REFERENCED COMPONENTS. THIS MODIFICATION ADDS A STEP TO THE INSPECTION PROCEDURE BY UTILIZING A GAGE TO AID IN THE INSPECTION OF THE SPIRALOCK TAPPED HOLE PRIOR TO TAPPING.
Current openFDA PMA Record#
- Device
- LCS TOTAL KNEE SYSTEM
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S091
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2005-09-12
- Decision code
- APPR
- Date received
- 2005-08-29
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE IN THE CRITERIA USED IN THE MANUFACTURE OF THE REFERENCED COMPONENTS. THIS MODIFICATION ADDS A STEP TO THE INSPECTION PROCEDURE BY UTILIZING A GAGE TO AID IN THE INSPECTION OF THE SPIRALOCK TAPPED HOLE PRIOR TO TAPPING.