|
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 | S056 |
Date Received | 01/21/2021 |
Decision Date | 02/17/2021 |
Product Code |
LOE |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Qualify and approve an alternate, proposed supplier to provide thermoformed PETG packaging trays and lids utilized in the final sterile pack assembly of EBI OsteoGen Surgically Implantable Bone Growth Stimulators and SpF Implantable Spinal Fusion Stimulators. |