|
Device | SpF Implantable Spinal Fusion Stimulators |
Generic Name | Stimulator, invasive bone growth |
Applicant | EBI, LLC 1 Gatehall Drive Suite 303 Parsippany, NJ 07054 |
PMA Number | P850035 |
Supplement Number | S054 |
Date Received | 12/14/2018 |
Decision Date | 10/24/2019 |
Product Code |
LOE |
Advisory Committee |
Orthopedic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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. |