SpF Implantable Spinal Fusion Stimulators
FDA premarket approval P850035/S057 · decided 2022-08-25
Approval details
- PMA number
- P850035
- Supplement
- S057
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SpF Implantable Spinal Fusion Stimulators
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2022-05-27
- Decision date
- 2022-08-25
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Approval for executing an ethylene oxide terminal sterilization process validation to align with applicable requirements of ISO 11135:2014 (14-529).
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