PMA P010014S014
- Device
- OXFORD UNICOMPARTMENTAL KNEE SYSTEM
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S014
- Product code
- NRA
- Decision date
- 2011-08-05
- Classification
- Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-constrained, Metal/polymer, Mobile Bearing
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- APPROVAL FOR MANUFACTURING SITES LOCATED AT BIOMET ORTHOPEDICS, INC., IN WARSAW, INDIANA, AND STERIS INC., LOCATED AT ISOMEDIX SERVICES, IN LIBERTYVILLE, ILLINOIS.
Current openFDA PMA Record#
- Device
- OXFORD UNICOMPARTMENTAL KNEE SYSTEM
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S014
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2011-08-05
- Decision code
- APPR
- Date received
- 2006-12-26
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR MANUFACTURING SITES LOCATED AT BIOMET ORTHOPEDICS, INC., IN WARSAW, INDIANA, AND STERIS INC., LOCATED AT ISOMEDIX SERVICES, IN LIBERTYVILLE, ILLINOIS.