Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | EBI OsteoGen Implantable Bone Growth Stimulators |
Generic Name | Stimulator, invasive bone growth |
Applicant | EBI, LLC a Highridge Medical Company 1 Gatehall Drive Suite 303 Parsippany, NJ 07054 |
PMA Number | P790005 |
Supplement Number | S059 |
Date Received | 03/01/2018 |
Decision Date | 03/30/2018 |
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 Qualification of an alternate-secondary, contract service provider to provide calibration, maintenance, and rental services of instrumentation and equipment used during qualification and validation activities for the EBI OsteoGen Implantable Gone Growth Stimulators, SpF Implantable Spinal Fusion Stimulators, Biomet EBI Bone Healing System, Biomet SpinalPak, and the Biomet OrthoPak. |
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