- Device
- SpF® Implantable Spinal Fusion Stimulators
- Applicant
- Ahp Eos Buyer, Inc.
- PMA number
- P850035
- Supplement
- S058
- Product code
- LOE
- Generic name
- Stimulator, invasive bone growth
- Decision date
- 2022-11-23
- Decision code
- OK30
- Date received
- 2022-10-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualify an alternate contract service provider to provide calibration services for instrumentation and lab equipment utilized to support manufacturing and quality operations.