|
Device | EBI OsteoGen Implantable Bone Growth Stimulators |
Generic Name | Stimulator, invasive bone growth |
Applicant | EBI, LLC 1 Gatehall Drive Suite 303 Parsippany, NJ 07054 |
PMA Number | P790005 |
Supplement Number | S062 |
Date Received | 04/02/2018 |
Decision Date | 11/02/2018 |
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 for implementation of an additional finished device cleaning process and associated new, semi- automated, PLC cleaning equipment to further ensure adequate removal of manufacturing materials and residue from finished devices has occurred through conformance to cleanliness requirements in accordance with Zimmer Biomet GES 09802 Implant Residual Materials and Endotoxin Limits. |