PMA P020016S013
- Device
- Total Temporomandibular Joint Replacement System
- Applicant
- Biomet Microfixation, Inc.
- PMA number
- P020016
- Supplement
- S013
- Product code
- LZD
- Decision date
- 2026-02-19
- Classification
- Dental
- Generic name
- Joint, temporomandibular, implant
- Approval order statement
- to include a surface roughness inspection method for the Total Temporomandibular Joint Replacement system (TMJ)
Current openFDA PMA Record#
- Device
- Total Temporomandibular Joint Replacement System
- Applicant
- Biomet Microfixation, Inc.
- PMA number
- P020016
- Supplement
- S013
- Product code
- LZD
- Generic name
- Joint, temporomandibular, implant
- Decision date
- 2026-02-19
- Decision code
- OK30
- Date received
- 2026-01-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to include a surface roughness inspection method for the Total Temporomandibular Joint Replacement system (TMJ)