- Device
- Biomet OrthoPak Non-invasive Bone Growth Stimulator System and Biomet SpinalPak Non-invasive Spine Fusion Stimulator Sys
- Applicant
- Ahp Eos Buyer, Inc.
- PMA number
- P850022
- Supplement
- S030
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 2019-12-03
- Decision code
- APPR
- Date received
- 2019-09-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a modification to the cable housing material and design.