FDA.reportPublic FDA data

PMA P790002S037

Device
Biomet EBI Bone Healing System
Applicant
Ahp Eos Buyer, Inc.
PMA number
P790002
Supplement
S037
Product code
LOF
Decision date
2018-03-30
Classification
Stimulator, Bone Growth, Non-invasive
Generic name
Stimulator, bone growth, non-invasive
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.

Current openFDA PMA Record#

Device
Biomet EBI Bone Healing System
Applicant
Ahp Eos Buyer, Inc.
PMA number
P790002
Supplement
S037
Product code
LOF
Generic name
Stimulator, bone growth, non-invasive
Decision date
2018-03-30
Decision code
OK30
Date received
2018-03-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.