SpF Implantable Spinal Fusion Stimulators
FDA premarket approval P850035/S054 · decided 2019-10-24
Approval details
- PMA number
- P850035
- Supplement
- S054
- Supplement type
- 135 Review Track For 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
- 2018-12-14
- Decision date
- 2019-10-24
- Days to decision
- 314 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Approval to qualify and place into service an upgraded and redesigned Reverse Osmosis, Deionized (RO/DI) Water System along with its ancillary equipment and components at Zimmer Biomets, EBI Patient Care, Guaynabo, Puerto Rico Manufacturing and Distribution Facility.
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