|
Device | EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR |
Generic Name | Stimulator, invasive bone growth |
Applicant | EBI, LLC 1 Gatehall Drive Suite 303 Parsippany, NJ 07054 |
PMA Number | P850035 |
Supplement Number | S042 |
Date Received | 02/19/2016 |
Decision Date | 03/18/2016 |
Product Code |
LOE |
Advisory Committee |
Orthopedic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of the following contraindication to the labeling: “Any case where SpF Spinal Fusion Stimulators could come into contact with metallic implant components (i.e., those that contain a mixture of Titanium, Cobalt Chrome, and Stainless Steel).” |