- Device
- Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System, Biomet® OrthoPak® Non-invasive Bone Growth Stimulator Sy
- Applicant
- Ahp Eos Buyer, Inc.
- PMA number
- P850022
- Supplement
- S032
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 2023-09-01
- Decision code
- OK30
- Date received
- 2023-08-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualify an alternate supplier to provide a replacement, non-smart, Lithium-ion battery pack solution.