FDA.reportPublic FDA data

PMA P790005S058

Device
EBI OsteoGen Implantable Bone Growth Stimulators
Applicant
Ahp Eos Buyer, Inc.
PMA number
P790005
Supplement
S058
Product code
LOE
Decision date
2018-03-14
Classification
Stimulator, Invasive Bone Growth
Generic name
Stimulator, invasive bone growth
Approval order statement
Addition of an alternate supplier to provide clean room contract certification services and High Efficiency Particulate Air (HEPA) filter distribution services for both the SpF Implantable Spinal Fusion System and the EBI OsteoGen Implantable Bone Growth Stimulator.

Current openFDA PMA Record#

Device
EBI OsteoGen Implantable Bone Growth Stimulators
Applicant
Ahp Eos Buyer, Inc.
PMA number
P790005
Supplement
S058
Product code
LOE
Generic name
Stimulator, invasive bone growth
Decision date
2018-03-14
Decision code
OK30
Date received
2018-02-21
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of an alternate supplier to provide clean room contract certification services and High Efficiency Particulate Air (HEPA) filter distribution services for both the SpF Implantable Spinal Fusion System and the EBI OsteoGen Implantable Bone Growth Stimulator.