PMA P980052S007
- Device
- Patient-Fitted TMJ Reconstruction Prosthesis System
- Applicant
- Stryker Leibinger, GmbH & Co KG
- PMA number
- P980052
- Supplement
- S007
- Product code
- LZD
- Decision date
- 2020-01-10
- Generic name
- Joint, temporomandibular, implant
- Approval order statement
- Approval for a manufacturing site located at TMJ Concepts, 6059 King Drive, Ventura, California.
Current openFDA PMA Record#
- Device
- Patient-Fitted TMJ Reconstruction Prosthesis System
- Applicant
- Stryker Leibinger, GmbH & Co KG
- PMA number
- P980052
- Supplement
- S007
- Product code
- LZD
- Generic name
- Joint, temporomandibular, implant
- Decision date
- 2020-01-10
- Decision code
- APPR
- Date received
- 2019-07-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at TMJ Concepts, 6059 King Drive, Ventura, California.