SpF Implantable Spinal Fusion Stimulators
FDA premarket approval P850035/S050 · decided 2018-04-26
Approval details
- PMA number
- P850035
- Supplement
- S050
- Supplement type
- 30-Day Notice
- 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
- 2018-03-29
- Decision date
- 2018-04-26
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Qualification and implementation of digitally-controlled vacuum sealing equipment to replace the analog vacuum sealing equipment.
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